Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: [18F]F-AraG

• Registration Number: NCT02323893
• Lead Sponsor: CellSight Technologies, Inc.

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.

Detailed Description

A positron emission tomography (PET) imaging tracer will be intravenously injected into healthy human volunteers who provide informed consent. Following injection of this tracer each volunteer will have four whole-body PET scans inside a PET scanner to obtain images of tracer biodistribution at four different time points. This will allow studying the kinetics of the tracer as well analysis of tracer dosimetry. Safety of the tracer will also be analyzed in each volunteer.

Study Timeline

• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Study Start: 2015-02
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Healthy human subjects without history of chronic disease or at present an acute disease will be included.
• Ability to abide by the study conditions is also a requirement for inclusion.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FAraG	[18F]F-AraG	A single dose intravenous injection of 18F-FAraG followed by PET scanning.

Primary Outcome Measures

Name	Time	Method
Visualize biodistribution of the PET tracer [18F]F-AraG	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	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	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.

Trial Locations

Locations (1)

UCSF Imaging Center at China Basin; 🇺🇸 San Francisco, California, United States