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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: [18F]F-AraG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FAraG<br>A single dose intravenous injection of 18F-FAraG followed by PET scanning. | Drug: [18F]F-AraG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography, Cancer Immunotherapy