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

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ClinicalTrials.gov Identifier: NCT02323893
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017
Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02323893


Contacts
Contact: Henry VanBrocklin, Ph.D. 415-353-4569 henry.vanbrocklin@radiology.ucsf.edu
Contact: Samuel Quezada, MBA 650-799-1589 squezada@cellsighttech.com

Locations
United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Kenneth Gao    415-353-9437    kenneth.gao@ucsf.edu   
Sub-Investigator: Shahriar Yaghoubi, Ph.D., MBA         
Principal Investigator: Randall Hawkins, M.D.         
Sub-Investigator: Benjamin Franc, M.D.         
Sponsors and Collaborators
CellSight Technologies, Inc.
Investigators
Principal Investigator: Henry VanBrocklin, Ph.D. University of California, San Francisco
More Information

Additional Information:
Publications:
Responsible Party: CellSight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02323893     History of Changes
Other Study ID Numbers: 261201300063
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

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