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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02323893

Enrollment

Registered

2014-12-24

Start date

2015-02-28

Completion date

2017-12-31

Last updated

2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Positron Emission Tomography, Cancer Immunotherapy

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.

Interventions

DRUG[18F]F-AraG

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026