Trial Outcomes & Findings for EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations (NCT NCT04812080)
NCT ID: NCT04812080
Last Updated: 2023-04-07
Results Overview
To collect preliminary data about total body FDG perfusion and early biodistribution in a cohort of racial/ethnic minority volunteers as measured by standardized uptake value (SUV) in gm/ml reported as Mean and Standard Deviation. The SUV is the ratio of the image-derived radioactivity concentration and the whole body concentration of the infected radioactivity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
3 hours
Results posted on
2023-04-07
Participant Flow
Participant milestones
| Measure |
EXPLORER PET/CT Imaging
Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study.
EXPLORER PET/CT: FDG PET Scans on the total body EXPLORER PET/CT scanner
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
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20
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations
Baseline characteristics by cohort
| Measure |
EXPLORER PET/CT Imaging
n=20 Participants
Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study.
EXPLORER PET/CT: FDG PET Scans on the total body EXPLORER PET/CT scanner
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|---|---|
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Age, Continuous
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51.52 years
n=5 Participants
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
|
7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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5 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=5 Participants
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Race (NIH/OMB)
White
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6 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 3 hoursPopulation: All the participants completed their scheduled scans at three timepoints: dynamic scan for 60 minutes, two scans at 90- and 120-minutes post-injection, for 20-minutes each.
To collect preliminary data about total body FDG perfusion and early biodistribution in a cohort of racial/ethnic minority volunteers as measured by standardized uptake value (SUV) in gm/ml reported as Mean and Standard Deviation. The SUV is the ratio of the image-derived radioactivity concentration and the whole body concentration of the infected radioactivity.
Outcome measures
| Measure |
EXPLORER PET/CT Imaging
n=20 Participants
Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study.
EXPLORER PET/CT: FDG PET Scans on the total body EXPLORER PET/CT scanner
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|---|---|
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Brain @ 40 minutes
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7.293 gm/ml
Standard Deviation 1.678
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Brain @ 90 minutes
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5.157 gm/ml
Standard Deviation 1.323
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Brain @ 120 minutes
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4.429 gm/ml
Standard Deviation 1.141
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Aorta @ 40 minutes
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2.357 gm/ml
Standard Deviation 0.208
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Aorta @ 90 minutes
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1.039 gm/ml
Standard Deviation 0.123
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Aorta @ 120 minutes
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0.794 gm/ml
Standard Deviation 0.089
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Liver @ 40 minutes
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2.639 gm/ml
Standard Deviation 0.285
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Liver @ 90 minutes
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1.215 gm/ml
Standard Deviation 0.156
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Liver @ 120 minutes
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0.966 gm/ml
Standard Deviation 0.109
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Spleen @ 40 minutes
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2.029 gm/ml
Standard Deviation 0.254
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Spleen @ 90 minutes
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1.019 gm/ml
Standard Deviation 0.130
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Spleen @ 120 minutes
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0.846 gm/ml
Standard Deviation 0.130
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Vertebrae @ 40 minutes
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1.380 gm/ml
Standard Deviation 0.186
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Vertebrae @ 90 minutes
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0.839 gm/ml
Standard Deviation 0.137
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Vertebrae @ 120 minutes
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0.712 gm/ml
Standard Deviation 0.125
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Skeletal muscle @ 40 minutes
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0.768 gm/ml
Standard Deviation 0.068
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Skeletal muscle @ 90 minutes
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0.425 gm/ml
Standard Deviation 0.052
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Skeletal muscle @ 120 minutes
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0.353 gm/ml
Standard Deviation 0.049
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Subcutaneous fat @ 40 minutes
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0.451 gm/ml
Standard Deviation 0.078
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Subcutaneous fat @ 90 minutes
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0.207 gm/ml
Standard Deviation 0.037
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Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
Subcutaneous fat @ 120 minutes
|
0.155 gm/ml
Standard Deviation 0.027
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PRIMARY outcome
Timeframe: 15 minutesParticipants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis
Outcome measures
| Measure |
EXPLORER PET/CT Imaging
n=20 Participants
Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study.
EXPLORER PET/CT: FDG PET Scans on the total body EXPLORER PET/CT scanner
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|---|---|
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Count of Participants With Confirmed Ancestry Informative Markers
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20 Participants
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Adverse Events
EXPLORER PET/CT Imaging
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