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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02323893
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
CellSight Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: [18F]F-AraG Phase 1

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  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02323893

United States, California
UCSF Imaging Center at China Basin
San Francisco, California, United States, 94107
Sponsors and Collaborators
CellSight Technologies, Inc.
Principal Investigator: Henry VanBrocklin, Ph.D. University of California, San Francisco

Additional Information:
Publications of Results:
Responsible Party: CellSight Technologies, Inc. Identifier: NCT02323893     History of Changes
Other Study ID Numbers: 261201300063
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Keywords provided by CellSight Technologies, Inc.:
Positron Emission Tomography
Cancer Immunotherapy