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

CellSight Technologies, Inc.6 enrolled

Overview

The goal of this study is to visualize biodistribution of a PET tracer called \[18F\]F-AraG through time in healthy human volunteers.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

[18F]F-AraGDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UCSF Imaging Center at China Basin

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 8 days

Data from ClinicalTrials.gov

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