Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans
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
1 other identifier
interventional
6
1 country
1
Brief Summary
The goal of this study is to visualize biodistribution of a PET tracer called \[18F\]F-AraG through time in healthy human volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 cancer
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMay 17, 2018
May 1, 2018
2.9 years
December 16, 2014
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Visualize biodistribution of the PET tracer [18F]F-AraG
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.
1 day
Analyze human dosimetry of [18F]F-AraG
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.
1 day
Assess acute safety of intravenously injected trace dose of [18F]F-AraG
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.
8 days
Study Arms (1)
18F-FAraG
EXPERIMENTALA single dose intravenous injection of 18F-FAraG followed by PET scanning.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy human subjects without history of chronic disease or at present an acute disease will be included.
You may not qualify if:
- Individuals under the age of 18 years and pregnant women will be excluded from the \[18F\]F-AraG imaging studies.
- Women who are breast-feeding will be excluded from the study.
- Individuals unable to provide informed consent will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Imaging Center at China Basin
San Francisco, California, 94107, United States
Related Publications (1)
Namavari M, Chang YF, Kusler B, Yaghoubi S, Mitchell BS, Gambhir SS. Synthesis of 2'-deoxy-2'-[18F]fluoro-9-beta-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET. Mol Imaging Biol. 2011 Oct;13(5):812-8. doi: 10.1007/s11307-010-0414-x.
PMID: 20838911RESULT
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Henry VanBrocklin, Ph.D.
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2014
First Posted
December 24, 2014
Study Start
February 1, 2015
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
May 17, 2018
Record last verified: 2018-05