Trial Outcomes & Findings for A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes (NCT NCT04594941)
NCT ID: NCT04594941
Last Updated: 2023-08-01
Results Overview
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Up to 2 weeks
Results posted on
2023-08-01
Participant Flow
This study was conducted at 5 centers in the United States from 27 January 2022 and 26 May 2022.
A total of 38 participants were enrolled, of which 35 were randomized into 1 of 4 sequences: Solid phase extraction (SPE)-SPE, high performance liquid chromatography (HPLC)-HPLC, SPE-HPLC, HPLC-SPE) to receive either 2 doses of Flurpiridaz (18F) Injection manufactured by the same process (HPLC or SPE) or 2 doses manufactured by different processes (1 dose by HPLC and 1 dose by SPE in a random order).
Participant milestones
| Measure |
Treatment Sequence: SPE-SPE
Participants received 2 intravenous (IV) boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 millicurie (mCi) (63 to 93 megabecquerel \[MBq\]) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: HPLC-HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: SPE-HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by SPE followed by 1 dose manufactured by HPLC) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: HPLC-SPE
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by HPLC followed by 1 dose manufactured by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
11
|
7
|
|
Overall Study
Modified Intent-to-Treat (mITT) Population
|
7
|
7
|
10
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence: SPE-SPE
Participants received 2 intravenous (IV) boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 millicurie (mCi) (63 to 93 megabecquerel \[MBq\]) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: HPLC-HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: SPE-HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by SPE followed by 1 dose manufactured by HPLC) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: HPLC-SPE
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by HPLC followed by 1 dose manufactured by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|---|
|
Overall Study
Other
|
0
|
3
|
1
|
0
|
Baseline Characteristics
A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
Baseline characteristics by cohort
| Measure |
Treatment Sequence: SPE-SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: HPLC-HPLC
n=10 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: SPE-HPLC
n=11 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by SPE followed by 1 dose manufactured by HPLC) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Treatment Sequence: HPLC-SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by HPLC followed by 1 dose manufactured by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 7.30 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 8.71 • n=7 Participants
|
66.0 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 10.30 • n=4 Participants
|
64.8 years
STANDARD_DEVIATION 8.94 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods is counted once in each group.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=31 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=31 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
Median of Readers
|
6.662 score on a scale
Standard Error 1.818
|
6.513 score on a scale
Standard Error 1.818
|
—
|
|
Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
Reader 1
|
6.235 score on a scale
Standard Error 1.846
|
6.219 score on a scale
Standard Error 1.846
|
—
|
|
Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
Reader 2
|
7.009 score on a scale
Standard Error 2.056
|
6.256 score on a scale
Standard Error 2.056
|
—
|
|
Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
Reader 3
|
7.336 score on a scale
Standard Error 1.831
|
7.246 score on a scale
Standard Error 1.831
|
—
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods was counted once in each group.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Summed score of the 17 segments SRS was used for analysis. SR% is calculated by dividing the SRS by a number corresponding to the SRS value indicating a deficit of 4 in every segment and then multiplying the result by 100. Intra-reader difference of SR% for PET MPI was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=31 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=31 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
Median of Readers
|
9.797 percentage of score
Standard Error 2.673
|
9.578 percentage of score
Standard Error 2.673
|
—
|
|
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
Reader 1
|
9.168 percentage of score
Standard Error 2.714
|
9.146 percentage of score
Standard Error 2.714
|
—
|
|
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
Reader 2
|
10.307 percentage of score
Standard Error 3.023
|
9.200 percentage of score
Standard Error 3.023
|
—
|
|
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
Reader 3
|
10.789 percentage of score
Standard Error 2.692
|
10.655 percentage of score
Standard Error 2.692
|
—
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Pearson's correlation was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
Reader 1
|
1.000 Correlation coefficient of score
|
0.890 Correlation coefficient of score
|
0.787 Correlation coefficient of score
|
|
Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
Reader 2
|
0.997 Correlation coefficient of score
|
0.905 Correlation coefficient of score
|
0.881 Correlation coefficient of score
|
|
Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
Reader 3
|
0.999 Correlation coefficient of score
|
0.931 Correlation coefficient of score
|
0.910 Correlation coefficient of score
|
PRIMARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Kendall's tau-b was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
Reader 1
|
1.000 Correlation coefficient of score
|
0.732 Correlation coefficient of score
|
0.769 Correlation coefficient of score
|
|
Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
Reader 2
|
0.856 Correlation coefficient of score
|
0.872 Correlation coefficient of score
|
0.869 Correlation coefficient of score
|
|
Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
Reader 3
|
1.000 Correlation coefficient of score
|
0.733 Correlation coefficient of score
|
0.833 Correlation coefficient of score
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. Here, "overall number of participants analyzed" signifies the participants with non-missing values receiving 2 doses with the same manufacturing process (either SPE-SPE or HPLC-HPLC). A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods was counted once in each group.
Variability of SRS was estimated by using the SD of the paired difference divided by square root of 2. SRS was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Variability of the SRS after MPI sessions using 2 Flurpiridaz (18F) injection doses by the same process was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
Reader 1
|
0.35 (units on a scale)/(square root 2)
|
3.20 (units on a scale)/(square root 2)
|
—
|
|
Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
Reader 2
|
2.67 (units on a scale)/(square root 2)
|
2.06 (units on a scale)/(square root 2)
|
—
|
|
Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
Reader 3
|
1.07 (units on a scale)/(square root 2)
|
3.67 (units on a scale)/(square root 2)
|
—
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
Percentage of participants with intra-reader agreement of the detected ischemic defect on PET-MPI was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses
Reader 1
|
100.0 percentage of participants
|
71.4 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses
Reader 2
|
85.7 percentage of participants
|
100.0 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses
Reader 3
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
Perfusion rest score was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal: 0; Minimal, mild impairment of perfusion, ambiguous image: 1; Moderate impairment of perfusion: 2; Significant impairment of perfusion: 3, No perfusion: 4. Higher score indicates impairment. Mean of the paired difference between the perfusion rest scores from 2 manufacturing processes for each of the 17 segments and each reader for 2 Flurpiridaz (18F) injection doses from same and different manufacturing process was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 8 - Mid Anteroseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
-0.176 Difference of scores
Interval -0.503 to 0.15
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 9 - Mid Inferoseptal
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
0.000 Difference of scores
Interval -0.534 to 0.534
|
0.059 Difference of scores
Interval -0.227 to 0.345
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 10 - Mid Inferior
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
0.143 Difference of scores
Interval -0.495 to 0.781
|
-0.294 Difference of scores
Interval -0.801 to 0.212
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 11 - Mid Inferolateral
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
0.143 Difference of scores
Interval -0.495 to 0.781
|
0.000 Difference of scores
Interval -0.182 to 0.182
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 12 - Mid Anterolateral
|
0.429 Difference of scores
Interval -0.62 to 1.477
|
0.143 Difference of scores
Interval -0.207 to 0.492
|
0.235 Difference of scores
Interval -0.264 to 0.734
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 13 - Apical Anterior
|
0.571 Difference of scores
Interval -0.827 to 1.97
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.118 Difference of scores
Interval -0.288 to 0.053
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 14 - Apical Septal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.689 to 0.975
|
0.059 Difference of scores
Interval -0.162 to 0.279
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 1 - Basal Anterior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.118 Difference of scores
Interval -0.367 to 0.132
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 2 - Basal Anteroseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.286 Difference of scores
Interval -0.985 to 0.413
|
0.059 Difference of scores
Interval -0.227 to 0.345
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 3 - Basal Inferoseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.714 Difference of scores
Interval -1.874 to 0.445
|
0.059 Difference of scores
Interval -0.162 to 0.279
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 4 - Basal Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.286 Difference of scores
Interval -0.594 to 1.165
|
0.235 Difference of scores
Interval -0.152 to 0.622
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 5 - Basal Inferolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.714 Difference of scores
Interval -0.669 to 2.098
|
0.000 Difference of scores
Interval -0.182 to 0.182
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 6 - Basal Anterolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
-0.471 Difference of scores
Interval -0.956 to 0.014
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 7 - Mid Anterior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.207 to 0.492
|
-0.235 Difference of scores
Interval -0.577 to 0.106
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 8 - Mid Anteroseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.059 Difference of scores
Interval -0.28 to 0.397
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 9 - Mid Inferoseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.059 Difference of scores
Interval -0.227 to 0.345
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 10 - Mid Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.981 to 1.267
|
0.059 Difference of scores
Interval -0.162 to 0.279
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 11 - Mid Inferolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.571 Difference of scores
Interval -0.827 to 1.97
|
0.118 Difference of scores
Interval -0.132 to 0.367
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 12 - Mid Anterolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.059 Difference of scores
Interval -0.521 to 0.404
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 13 - Apical Anterior
|
0.143 Difference of scores
Interval -0.207 to 0.492
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
0.412 Difference of scores
Interval -0.071 to 0.895
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 14 - Apical Septal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.689 to 0.975
|
0.059 Difference of scores
Interval -0.066 to 0.184
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 15 - Apical Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
-0.176 Difference of scores
Interval -0.698 to 0.345
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 16 - Apical Lateral
|
0.143 Difference of scores
Interval -0.207 to 0.492
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval -0.406 to 0.406
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 1: Segment 17 - Apex
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.286 Difference of scores
Interval -0.991 to 1.562
|
0.000 Difference of scores
Interval -0.364 to 0.364
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 1 - Basal Anterior
|
-0.429 Difference of scores
Interval -1.477 to 0.62
|
0.286 Difference of scores
Interval -0.166 to 0.737
|
-0.235 Difference of scores
Interval -0.524 to 0.054
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 2 - Basal Anteroseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval -0.534 to 0.534
|
-0.176 Difference of scores
Interval -0.448 to 0.095
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 3 - Basal Inferoseptal
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
0.286 Difference of scores
Interval -0.594 to 1.165
|
0.059 Difference of scores
Interval -0.162 to 0.279
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 4 - Basal Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.286 Difference of scores
Interval -0.594 to 1.165
|
-0.235 Difference of scores
Interval -0.622 to 0.152
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 5 - Basal Inferolateral
|
0.429 Difference of scores
Interval -0.62 to 1.477
|
0.000 Difference of scores
Interval -1.413 to 1.413
|
0.176 Difference of scores
Interval -0.15 to 0.503
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 6 - Basal Anterolateral
|
0.286 Difference of scores
Interval -0.874 to 1.445
|
-0.143 Difference of scores
Interval -0.975 to 0.689
|
0.000 Difference of scores
Interval -0.603 to 0.603
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 7 - Mid Anterior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.176 Difference of scores
Interval -0.379 to 0.026
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 15 - Apical Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.143 Difference of scores
Interval -0.781 to 0.495
|
0.176 Difference of scores
Interval -0.533 to 0.886
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 16 - Apical Lateral
|
0.143 Difference of scores
Interval -0.689 to 0.975
|
-0.286 Difference of scores
Interval -0.985 to 0.413
|
-0.176 Difference of scores
Interval -0.698 to 0.345
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 2: Segment 17 - Apex
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
-0.571 Difference of scores
Interval -1.62 to 0.477
|
0.118 Difference of scores
Interval -0.191 to 0.426
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 1 - Basal Anterior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.429 Difference of scores
Interval -0.62 to 1.477
|
-0.118 Difference of scores
Interval -0.288 to 0.053
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 2 - Basal Anteroseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.429 Difference of scores
Interval -0.62 to 1.477
|
0.059 Difference of scores
Interval -0.162 to 0.279
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 3 - Basal Inferoseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.689 to 0.975
|
-0.059 Difference of scores
Interval -0.279 to 0.162
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 4 - Basal Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.286 Difference of scores
Interval -0.413 to 0.985
|
0.059 Difference of scores
Interval -0.066 to 0.184
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 5 - Basal Inferolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.286 Difference of scores
Interval -1.95 to 1.379
|
0.235 Difference of scores
Interval -0.355 to 0.825
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 6 - Basal Anterolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.059 Difference of scores
Interval -0.279 to 0.162
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 7 - Mid Anterior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.286 Difference of scores
Interval -0.413 to 0.985
|
-0.118 Difference of scores
Interval -0.288 to 0.053
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 8 - Mid Anteroseptal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.207 to 0.492
|
0.118 Difference of scores
Interval -0.284 to 0.519
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 9 - Mid Inferoseptal
|
-0.429 Difference of scores
Interval -1.477 to 0.62
|
0.143 Difference of scores
Interval -0.207 to 0.492
|
-0.176 Difference of scores
Interval -0.379 to 0.026
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 10 - Mid Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.429 Difference of scores
Interval -0.299 to 1.156
|
0.176 Difference of scores
Interval -0.095 to 0.448
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 11 - Mid Inferolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.143 Difference of scores
Interval -0.689 to 0.975
|
0.118 Difference of scores
Interval -0.424 to 0.659
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 12 - Mid Anterolateral
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.176 Difference of scores
Interval -0.448 to 0.095
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 13 - Apical Anterior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.118 Difference of scores
Interval -0.132 to 0.367
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 14 - Apical Septal
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.176 Difference of scores
Interval -0.095 to 0.448
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 15 - Apical Inferior
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.000 Difference of scores
Interval -0.481 to 0.481
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 16 - Apical Lateral
|
-0.143 Difference of scores
Interval -0.492 to 0.207
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
-0.118 Difference of scores
Interval -0.559 to 0.323
|
|
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Reader 3: Segment 17 - Apex
|
0.000 Difference of scores
Interval 0.0 to 0.0
|
0.857 Difference of scores
Interval -0.598 to 2.312
|
-0.176 Difference of scores
Interval -0.698 to 0.345
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
Difference was calculated by (Mean SUV from the second injection - Mean SUV from the first injection). SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose \[MBq\] / Weight (kilogram \[kg\]). Difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Blood
|
2.445 percent
Standard Deviation 1.3493
|
1.677 percent
Standard Deviation 0.6376
|
2.097 percent
Standard Deviation 1.2356
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Liver
|
1.208 percent
Standard Deviation 0.6282
|
0.994 percent
Standard Deviation 0.7682
|
1.635 percent
Standard Deviation 1.6405
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Lung
|
1.652 percent
Standard Deviation 0.8000
|
1.507 percent
Standard Deviation 1.3117
|
1.110 percent
Standard Deviation 1.2815
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Anterior
|
1.218 percent
Standard Deviation 0.8081
|
1.418 percent
Standard Deviation 0.7167
|
2.390 percent
Standard Deviation 2.7086
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Anteroseptal
|
1.587 percent
Standard Deviation 0.8049
|
1.432 percent
Standard Deviation 0.6574
|
2.747 percent
Standard Deviation 2.8378
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Inferoseptal
|
1.839 percent
Standard Deviation 0.7109
|
1.490 percent
Standard Deviation 0.5679
|
2.439 percent
Standard Deviation 2.5590
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Inferior
|
1.582 percent
Standard Deviation 0.6831
|
1.365 percent
Standard Deviation 0.8715
|
2.144 percent
Standard Deviation 2.3601
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Inferolateral
|
1.429 percent
Standard Deviation 0.7059
|
1.467 percent
Standard Deviation 0.5900
|
2.187 percent
Standard Deviation 2.5969
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Anterolateral
|
1.477 percent
Standard Deviation 0.6315
|
1.612 percent
Standard Deviation 0.7959
|
2.390 percent
Standard Deviation 2.7995
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Anterior
|
1.715 percent
Standard Deviation 1.1142
|
1.322 percent
Standard Deviation 0.9838
|
2.409 percent
Standard Deviation 2.8687
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Anteroseptal
|
1.882 percent
Standard Deviation 1.0797
|
1.235 percent
Standard Deviation 0.7855
|
2.450 percent
Standard Deviation 2.8654
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Inferoseptal
|
2.085 percent
Standard Deviation 0.9045
|
1.538 percent
Standard Deviation 1.0105
|
2.330 percent
Standard Deviation 2.6850
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Inferior
|
2.132 percent
Standard Deviation 0.9901
|
1.564 percent
Standard Deviation 1.3300
|
2.211 percent
Standard Deviation 2.6039
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Inferolateral
|
1.815 percent
Standard Deviation 0.8898
|
1.387 percent
Standard Deviation 0.9522
|
2.511 percent
Standard Deviation 3.1065
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Anterolateral
|
1.847 percent
Standard Deviation 0.9456
|
1.408 percent
Standard Deviation 1.1032
|
2.605 percent
Standard Deviation 3.2431
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Anterior
|
1.641 percent
Standard Deviation 0.9567
|
0.897 percent
Standard Deviation 0.5750
|
2.286 percent
Standard Deviation 2.6271
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Septal
|
1.669 percent
Standard Deviation 0.9274
|
1.382 percent
Standard Deviation 1.1146
|
2.014 percent
Standard Deviation 2.3986
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Inferior
|
2.037 percent
Standard Deviation 0.7632
|
1.312 percent
Standard Deviation 0.9000
|
1.986 percent
Standard Deviation 2.1610
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Lateral
|
1.675 percent
Standard Deviation 1.0117
|
1.094 percent
Standard Deviation 0.7583
|
2.434 percent
Standard Deviation 2.7838
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apex
|
1.424 percent
Standard Deviation 0.7731
|
1.105 percent
Standard Deviation 0.8259
|
1.833 percent
Standard Deviation 1.9528
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Left Anterior Descending Artery (LAD)
|
1.357 percent
Standard Deviation 0.9189
|
1.065 percent
Standard Deviation 0.7425
|
2.102 percent
Standard Deviation 2.6262
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Left Circumflex Artery (LCX)
|
1.503 percent
Standard Deviation 0.7590
|
1.194 percent
Standard Deviation 0.5908
|
2.248 percent
Standard Deviation 2.9416
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Right Coronary Artery (RCA)
|
1.846 percent
Standard Deviation 0.7726
|
1.319 percent
Standard Deviation 0.8727
|
2.052 percent
Standard Deviation 2.4344
|
|
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Whole Myocardium
|
1.449 percent
Standard Deviation 0.7983
|
1.100 percent
Standard Deviation 0.7513
|
2.052 percent
Standard Deviation 2.7089
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
Relative difference was calculated as 100 (SUV1-SUV2) / (0.5\*\[SUV1 + SUV2\]) and SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose \[MBq\] / Weight \[kg\]). Relative difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Inferoseptal
|
7.157 percent
Standard Deviation 18.2437
|
-4.976 percent
Standard Deviation 19.2974
|
1.540 percent
Standard Deviation 16.5447
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Liver
|
5.965 percent
Standard Deviation 25.5980
|
-2.200 percent
Standard Deviation 21.7720
|
-6.042 percent
Standard Deviation 24.0731
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Lung
|
-2.647 percent
Standard Deviation 34.8133
|
-10.949 percent
Standard Deviation 35.3666
|
9.030 percent
Standard Deviation 39.7082
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Anterior
|
-1.991 percent
Standard Deviation 10.5622
|
-9.725 percent
Standard Deviation 17.1715
|
3.246 percent
Standard Deviation 13.6798
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Anteroseptal
|
1.031 percent
Standard Deviation 10.6386
|
-5.606 percent
Standard Deviation 20.6948
|
-2.130 percent
Standard Deviation 16.5611
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Blood
|
0.738 percent
Standard Deviation 27.4693
|
2.500 percent
Standard Deviation 32.0112
|
-12.260 percent
Standard Deviation 22.1399
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Inferior
|
3.199 percent
Standard Deviation 13.1457
|
-12.323 percent
Standard Deviation 21.9242
|
0.060 percent
Standard Deviation 17.9617
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Inferolateral
|
2.525 percent
Standard Deviation 14.1960
|
-14.008 percent
Standard Deviation 22.3971
|
-2.293 percent
Standard Deviation 15.4717
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Basal Anterolateral
|
0.007 percent
Standard Deviation 15.6644
|
-11.312 percent
Standard Deviation 18.2771
|
6.782 percent
Standard Deviation 12.5498
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Anterior
|
0.591 percent
Standard Deviation 17.8879
|
-12.036 percent
Standard Deviation 16.6875
|
3.186 percent
Standard Deviation 12.8762
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Anteroseptal
|
4.007 percent
Standard Deviation 15.5683
|
-7.183 percent
Standard Deviation 13.6480
|
0.789 percent
Standard Deviation 13.9519
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Inferoseptal
|
4.716 percent
Standard Deviation 17.7702
|
-12.442 percent
Standard Deviation 23.8374
|
-0.140 percent
Standard Deviation 14.7096
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Inferior
|
8.081 percent
Standard Deviation 21.0838
|
-14.493 percent
Standard Deviation 30.8501
|
-0.601 percent
Standard Deviation 16.8102
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Inferolateral
|
6.665 percent
Standard Deviation 15.4194
|
-12.251 percent
Standard Deviation 21.7680
|
-1.414 percent
Standard Deviation 18.0348
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Mid Anterolateral
|
3.024 percent
Standard Deviation 17.5448
|
-10.975 percent
Standard Deviation 14.4678
|
2.994 percent
Standard Deviation 13.5190
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Anterior
|
6.649 percent
Standard Deviation 18.1637
|
-3.935 percent
Standard Deviation 10.0975
|
1.708 percent
Standard Deviation 12.9038
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Septal
|
5.473 percent
Standard Deviation 17.0274
|
-6.934 percent
Standard Deviation 18.1451
|
0.802 percent
Standard Deviation 13.5151
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Inferior
|
1.624 percent
Standard Deviation 20.8841
|
-8.174 percent
Standard Deviation 15.6239
|
-2.135 percent
Standard Deviation 16.0488
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apical Lateral
|
2.404 percent
Standard Deviation 15.9485
|
-2.015 percent
Standard Deviation 12.7979
|
0.133 percent
Standard Deviation 17.6721
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Apex
|
5.073 percent
Standard Deviation 17.2269
|
-0.038 percent
Standard Deviation 15.2867
|
-2.059 percent
Standard Deviation 11.0612
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Left Anterior Descending Artery (LAD)
|
2.088 percent
Standard Deviation 13.6375
|
-7.123 percent
Standard Deviation 13.8785
|
1.212 percent
Standard Deviation 12.2860
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Left Circumflex Artery (LCX)
|
2.883 percent
Standard Deviation 14.1203
|
-8.554 percent
Standard Deviation 13.5718
|
-0.344 percent
Standard Deviation 15.0979
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Right Coronary Artery (RCA)
|
3.205 percent
Standard Deviation 16.8800
|
-9.506 percent
Standard Deviation 18.8804
|
-0.584 percent
Standard Deviation 15.3095
|
|
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Whole Myocardium
|
2.818 percent
Standard Deviation 14.3881
|
-8.226 percent
Standard Deviation 14.2067
|
0.577 percent
Standard Deviation 13.2035
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
Image quality scoring was performed as following: SPE image was worse than HPLC image when the difference (SPE - HPLC) score was less than or equal (\<=)-3. SPE image was slightly worse than HPTC image when the difference score was \<=-1 and greater than (\>)-3. SPE and HPLC images were the same when the difference score was \>-1 and less than (\<) 1. SPE image was slightly better when the difference score \>=1 and \<3. SPE image was better when the difference was \>=3. Higher score indicates better outcomes. Number of participants categorized based on intra-reader agreement of the image quality score between the 2 Sets of PET images for 2 Flurpiridaz (18F) injection doses from different manufacturing processes was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=17 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 1 · SPE image was worse than HPLC image
|
1 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 1 · SPE image was slightly worse than HPLC image
|
3 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 1 · SPE and HPLC images were the same
|
11 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 1 · SPE image was slightly better than HPLC image
|
2 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 1 · SPE image was better than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 2 · SPE image was worse than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 2 · SPE image was slightly worse than HPLC image
|
1 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 2 · SPE and HPLC images were the same
|
16 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 2 · SPE image was slightly better than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 2 · SPE image was better than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 3 · SPE image was worse than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 3 · SPE image was slightly worse than HPLC image
|
3 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 3 · SPE and HPLC images were the same
|
13 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 3 · SPE image was slightly better than HPLC image
|
1 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Perfusion Image Quality: Reader 3 · SPE image was better than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 1 · SPE image was worse than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 1 · SPE image was slightly worse than HPLC image
|
5 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 1 · SPE and HPLC images were the same
|
9 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 1 · SPE image was slightly better than HPLC image
|
3 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 1 · SPE image was better than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 2 · SPE image was worse than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 2 · SPE image was slightly worse than HPLC image
|
3 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 2 · SPE and HPLC images were the same
|
12 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 2 · SPE image was slightly better than HPLC image
|
2 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 2 · SPE image was better than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 3 · SPE image was worse than HPLC image
|
0 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 3 · SPE image was slightly worse than HPLC image
|
6 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 3 · SPE and HPLC images were the same
|
8 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 3 · SPE image was slightly better than HPLC image
|
3 Participants
|
—
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Gated Image Quality: Reader 3 · SPE image was better than HPLC image
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Analysis was performed on mITT population. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.
Image quality scoring was performed as following: 2 images were the same when the absolute difference score was \>=0 and \<1. 2 images were slightly different when the absolute difference score \>=1 and \<3. 2 images were different when the absolute difference score \>=3. Higher score indicates better outcomes. Number of participants categorized based on intra-reader agreement of the image quality score between the 2 sets of PET Images for 2 Flurpiridaz (18F) injection doses from same manufacturing processes was reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=7 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 1 · 2 images were the same
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 1 · 2 images were slightly different
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 1 · 2 images were different
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 2 · 2 images were the same
|
7 Participants
|
7 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 2 · 2 images were slightly different
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 2 · 2 images were different
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 3 · 2 images were the same
|
5 Participants
|
5 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 3 · 2 images were slightly different
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Perfusion Image Quality: Reader 3 · 2 images were different
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 1 · 2 images were the same
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 1 · 2 images were slightly different
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 1 · 2 images were different
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 2 · 2 images were the same
|
6 Participants
|
6 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 2 · 2 images were slightly different
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 2 · 2 images were different
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 3 · 2 images were the same
|
6 Participants
|
3 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 3 · 2 images were slightly different
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Gated Image Quality: Reader 3 · 2 images were different
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to end of follow up (up to 30 days)Population: The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Here, "overall number of participants analyzed" signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
A TEAE was defined as an adverse events (AE) that occurred from the time of investigational medicinal product (IMP) administration through the end of the follow-up period for the corresponding dose. Any medication error, clinically significant vital signs, electrocardiograms (ECGs), hematology, clinical chemistry laboratory tests, and urinalysis values determined by investigator were reported as TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
Outcome measures
| Measure |
Flurpiridaz (18F): SPE vs SPE
n=25 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC vs HPLC
n=27 Participants
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): SPE vs. HPLC
Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Flurpiridaz (18F): SPE
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Flurpiridaz (18F): HPLC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flurpiridaz (18F): SPE
n=25 participants at risk
Participants received either 1 or 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
Flurpiridaz (18F): HPLC
n=27 participants at risk
Participants received either 1 or 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
|
0.00%
0/27 • From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
|
|
Nervous system disorders
Dysgeusia
|
4.0%
1/25 • From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
|
3.7%
1/27 • From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.0%
1/25 • From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
|
0.00%
0/27 • From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
- Publication restrictions are in place
Restriction type: OTHER