Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|