Trial Outcomes & Findings for Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals (NCT NCT03125629)
NCT ID: NCT03125629
Last Updated: 2021-04-09
Results Overview
Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake value within the region of interest (ROI). SUVmax is calculated as the ratio of activity concentration:injected dose/body weight. The outcome is reported as the mean SUVmax with standard deviation (SD), reported for 8 specific organs or bodily locations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
4 hours
Results posted on
2021-04-09
Participant Flow
Most subjects participated in more than 1 treatment arm. In order to not have participants represented multiple times in Participant Flow, this information is provided only at the study level.
Participant milestones
| Measure |
Total Participant Flow
Participant Flow reflects participation of individual human participants. Individual participants are present in multiple assessment groups ("arms" or "cohorts").
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Total Participant Flow
Participant Flow reflects participation of individual human participants. Individual participants are present in multiple assessment groups ("arms" or "cohorts").
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Equipment malfunction
|
1
|
Baseline Characteristics
Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals
Baseline characteristics by cohort
| Measure |
Total Participants
n=53 Participants
Baseline information reflects participation of the individual human participants. Individual human participants are present in multiple assessment groups ("arms" or "cohorts"), and to avoid over-representation of those participants, data is not reported by group.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
54.34 years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Not all scans at all body locations could be completed.
Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake value within the region of interest (ROI). SUVmax is calculated as the ratio of activity concentration:injected dose/body weight. The outcome is reported as the mean SUVmax with standard deviation (SD), reported for 8 specific organs or bodily locations.
Outcome measures
| Measure |
18F-FDG PET/CT Scan
n=44 scans
Participants will undergo a PET/CT scan with radiolabel 18F-FDG.
F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
|
18F-FDG PET/MRI Scan
n=42 scans
Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.
F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner.
|
68Ga-DOTA-TATE PET/CT Scan
n=6 scans
Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
|
68Ga-DOTA-TATE PET/MRI Scan
n=6 scans
Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner.
|
|---|---|---|---|---|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Spleen
|
2.18 ratio
Standard Deviation 0.82
|
2.03 ratio
Standard Deviation 0.97
|
13.07 ratio
Standard Deviation 3.75
|
15.74 ratio
Standard Deviation 3.16
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Aortic arch
|
1.78 ratio
Standard Deviation 0.42
|
1.08 ratio
Standard Deviation 0.38
|
0.54 ratio
Standard Deviation 0.22
|
0.51 ratio
Standard Deviation 0.19
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Gluteal muscle
|
0.79 ratio
Standard Deviation 0.20
|
0.94 ratio
Standard Deviation 0.28
|
0.42 ratio
Standard Deviation 0.19
|
0.47 ratio
Standard Deviation 0.25
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Gluteal fat
|
0.27 ratio
Standard Deviation 0.10
|
0.26 ratio
Standard Deviation 0.09
|
0.14 ratio
Standard Deviation 0.06
|
0.24 ratio
Standard Deviation 0.07
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Cerebellum
|
8.56 ratio
Standard Deviation 2.64
|
7.79 ratio
Standard Deviation 2.49
|
0.22 ratio
Standard Deviation 0.09
|
0.12 ratio
Standard Deviation 0.12
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Parotid Gland
|
1.71 ratio
Standard Deviation 0.68
|
1.76 ratio
Standard Deviation 0.77
|
1.28 ratio
Standard Deviation 0.60
|
1.06 ratio
Standard Deviation 0.26
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Lung
|
0.57 ratio
Standard Deviation 0.21
|
0.36 ratio
Standard Deviation 0.15
|
0.31 ratio
Standard Deviation 0.05
|
0.26 ratio
Standard Deviation 0.20
|
|
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Liver
|
2.72 ratio
Standard Deviation 0.66
|
2.21 ratio
Standard Deviation 0.59
|
9.47 ratio
Standard Deviation 7.15
|
10.86 ratio
Standard Deviation 7.60
|
SECONDARY outcome
Timeframe: estimated average of 2 hoursPopulation: Not all scans at all body locations could be completed.
Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake within the region of interest (ROI). Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT and PET/MR. Percentage difference is expressed as the difference of the means in SUVmax for the PET/CT and PET/MRI scan procedures for the particular radiotracer, divided by the mean between the values for the 2 scan procedures. The closer the percent difference is to 0%, the better the agreement between the two scanners. The outcome is expressed as the percentage difference, a number without dispersion.
Outcome measures
| Measure |
18F-FDG PET/CT Scan
n=86 Scans (PET/CT + PET/MRI)
Participants will undergo a PET/CT scan with radiolabel 18F-FDG.
F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
|
18F-FDG PET/MRI Scan
n=12 Scans (PET/CT + PET/MRI)
Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.
F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner.
|
68Ga-DOTA-TATE PET/CT Scan
Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
|
68Ga-DOTA-TATE PET/MRI Scan
Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner.
|
|---|---|---|---|---|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Aortic arch
|
48.95 Percentage difference
|
5.71 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Gluteal muscle
|
17.34 Percentage difference
|
11.24 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Gluteal fat
|
3.77 Percentage difference
|
52.63 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Cerebellum
|
9.42 Percentage difference
|
58.82 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Parotid Gland
|
2.88 Percentage difference
|
18.80 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Lung
|
45.16 Percentage difference
|
17.54 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Liver
|
20.69 Percentage difference
|
13.67 Percentage difference
|
—
|
—
|
|
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
Spleen
|
7.13 Percentage difference
|
18.54 Percentage difference
|
—
|
—
|
Adverse Events
18F-FDG PET/CT Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
18F-FDG PET/MRI Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
68Ga-DOTA-TATE PET/CT Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
68Ga-DOTA-TATE PET/MRI Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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