Trial Outcomes & Findings for Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2 (NCT NCT01383135)
NCT ID: NCT01383135
Last Updated: 2024-01-12
Results Overview
Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.
COMPLETED
EARLY_PHASE1
27 participants
5 hours
2024-01-12
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.
|
Breast Cancer
4 to 11 mCi F18-FPPRGD2 by IV injection
|
Glioblastoma Multiform Patients
5 to14 mCi F18-FPPRGD2 by IV injection
|
Lung Cancer
X to XX mCi F18-FPPRGD2 by IV injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
9
|
4
|
|
Overall Study
COMPLETED
|
5
|
8
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healthy Volunteers
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.
|
Breast Cancer
4 to 11 mCi F18-FPPRGD2 by IV injection
|
Glioblastoma Multiform Patients
5 to14 mCi F18-FPPRGD2 by IV injection
|
Lung Cancer
X to XX mCi F18-FPPRGD2 by IV injection
|
|---|---|---|---|---|
|
Overall Study
Not Scanned / Imaged
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=6 Participants
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
Breast Cancer Patients
n=8 Participants
4 to 11 mCi F18-FPPRGD2 by IV injection
|
Glioblastoma Multiforme
n=9 Participants
5 to14 mCi F18-FPPRGD2 by IV injection
|
Lung Cancer
n=4 Participants
X to XX mCi F18-FPPRGD2 by IV injection
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 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
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 hoursPopulation: Per protocol, data were collected for this outcome from the Healthy Volunteers group only, and only those that completed all scans are included.
Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.
Outcome measures
| Measure |
Healthy Volunteers
n=4 Participants
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
|---|---|
|
Tracer Dosimetry by Organ
Kidneys
|
0.3603 mSv/MBq
Standard Deviation 0.1852
|
|
Tracer Dosimetry by Organ
Bladder
|
0.8615 mSv/MBq
Standard Deviation 0.4362
|
|
Tracer Dosimetry by Organ
Bowel
|
0.5290 mSv/MBq
Standard Deviation 0.2364
|
|
Tracer Dosimetry by Organ
Liver
|
0.0988 mSv/MBq
Standard Deviation 0.0379
|
PRIMARY outcome
Timeframe: 30, 60, and 90 minutes post-injectionPopulation: Per protocol, data were collected for this outcome from the Healthy Volunteers group only. 4/5 volunteers were able to complete all of the scans. 1/5 participant could only complete one of the four scans and was not included in pharmacokinetic calculations.
Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time.
Outcome measures
| Measure |
Healthy Volunteers
n=4 Participants
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
|---|---|
|
F18-FPPRGD2 Time-activity at Specified Timepoints
30 minutes post-injection
|
26 Percentage of tracer remaining in blood
Standard Deviation 17
|
|
F18-FPPRGD2 Time-activity at Specified Timepoints
60 minutes post-injection
|
18 Percentage of tracer remaining in blood
Standard Deviation 14
|
|
F18-FPPRGD2 Time-activity at Specified Timepoints
90 minutes post-injection
|
8 Percentage of tracer remaining in blood
Standard Deviation 2
|
PRIMARY outcome
Timeframe: 3 hoursPopulation: Per protocol, data were collected for this outcome from the Breast Cancer Patients group only. In a per-lesion analysis, a total of 30 lesions were evaluated at PET/CT scanning with F18-FPPRGD2.
Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as \[TP/ (TP+FN)\], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result.
Outcome measures
| Measure |
Healthy Volunteers
n=30 Lesions
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
|---|---|
|
Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer
|
95.7 percentage of sensitivity
|
PRIMARY outcome
Timeframe: an estimated average of 3 hoursPopulation: Per protocol, data were collected for this outcome from the Breast Cancer Patients group only. Other cohorts are not included, and the outcome was only assessed in the breast cancer cohort.
Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is: \[TN/ (TN+FP)\], where TN= true negative, and FP = false positive.
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
|---|---|
|
Specificity of F18 FPPRGD2 PET/CT in Breast Cancer
|
100 percentage of specificity
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Per protocol, data were collected for this outcome from the Glioblastoma Multiforme group only. Participants in the Glioblastoma Multiforme group who completed the imaging schedule were included in the analysis.
Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation.
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
|---|---|
|
Glioblastoma Primary Tumor Response Assessed by PET Scan
Pretreatment
|
1.7 SUVmax
Standard Deviation 0.6
|
|
Glioblastoma Primary Tumor Response Assessed by PET Scan
Week 6
|
1.3 SUVmax
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: Per protocol, data were collected for this outcome from the Glioblastoma Multiforme group only. Participants in the Glioblastoma Multiforme group who completed the imaging schedule were included in the analysis.
Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by computed tomography (CT) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the mean difference from baseline to week 6, with standard deviation.
Outcome measures
| Measure |
Healthy Volunteers
n=6 Participants
5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection
|
|---|---|
|
Glioblastoma Primary Tumor Response Assessed by CT Scan
|
-11.0 percentage change
Standard Deviation 80.7
|
Adverse Events
Healthy Volunteers
Breast Cancer Patients
Glioblastoma Multiforme
Lung Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place