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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FAraG

A single dose intravenous injection of 18F-FAraG followed by PET scanning.

Group Type EXPERIMENTAL

[18F]F-AraG

Intervention Type DRUG

Interventions

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[18F]F-AraG

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes