Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans
|ClinicalTrials.gov Identifier: NCT02323893|
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: [18F]F-AraG||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG, a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Healthy Humans|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
A single dose intravenous injection of 18F-FAraG followed by PET scanning.
- Visualize biodistribution of the PET tracer [18F]F-AraG [ Time Frame: 1 day ]Whole-body [18F]F-AraG PET scans will be performed at 4 different time points following intravenous injection of the PET tracer. Four whole-body images will be obtained that will reveal biodistribution of [18F]F-AraG at 4 different consecutive time points after intravenous injection.
- Analyze human dosimetry of [18F]F-AraG [ Time Frame: 1 day ]Time-Activity curves will be graphed by measuring activity in various organs at the 4 time points after tracer injection. From these time activity curves absorbed radiation will be calculated.
- Assess acute safety of intravenously injected trace dose of [18F]F-AraG [ Time Frame: 8 days ]Blood and urine samples may be collected at baseline and at 1 and 8 days after injection of [18F]F-AraG to perform metabolic panel, CBC and urine analysis. Vital signs and EKG will be measured and recorded at baseline, within 3 hours after tracer injection and at 1 and 8 days after tracer injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323893
|United States, California|
|UCSF Imaging Center at China Basin|
|San Francisco, California, United States, 94107|
|Principal Investigator:||Henry VanBrocklin, Ph.D.||University of California, San Francisco|