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

May 14, 2018 updated by: CellSight Technologies, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • UCSF Imaging Center at China Basin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualize biodistribution of the PET tracer [18F]F-AraG
Time Frame: 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.
1 day
Analyze human dosimetry of [18F]F-AraG
Time Frame: 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.
1 day
Assess acute safety of intravenously injected trace dose of [18F]F-AraG
Time Frame: 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.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellSight Technologies, Inc.

Investigators

  • Principal Investigator: Henry VanBrocklin, Ph.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 261201300063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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