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[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142204
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : December 5, 2022
Sponsor:
Collaborator:
UCSF Imaging Center at China Basin
Information provided by (Responsible Party):
CellSight Technologies, Inc.

Study Description
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Brief Summary:
This is a Phase 1 study is to visualize biodistribution of a PET tracer called [18F]F-AraG (VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.

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

Detailed Description:

This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation dosimetry of the Positron Emission Tomography [18F]FAraG (VisAcT) in cancer patients selected for immunotherapy and/or radiation therapy. Each patient may have up to two [ 18F]FAraG PET imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging session, patients will receive a single injection of [18F]FAraG and undergo a whole-body PET scans an hour after injection of the tracer. Following each imaging session, the patient will be called within 72 hours to note any side effects.

Optional - Blood samples may be collected at up to 9 time points post-injection to analyze whole-blood/plasma time activity of [18F]FAraG in addition an urine sample may be collected post scan.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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 (VisAcT), a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Cancer Patients Who Have Received or Are Expected to Receive Immunotherapy and/or Radiation Therapy
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: [18F]F-AraG
    Single dose IV injection of [18F]F-AraG for each imaging day.

Outcome Measures
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Primary Outcome Measures :
  1. Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy [ Time Frame: Up to 6 weeks before immunotherapy is administered ]
    Whole-body [18F]F-AraG PET scan will be performed after intravenous injection of the PET tracer.consecutive time points the day of the intravenous injection of the PET tracer.

  2. Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy [ Time Frame: Up to 12 weeks after start of immunotherapy ]
    Whole-body [18F]F-AraG PET scan will be performed after intravenous injection of the PET tracer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer patients with identified tumor mass
  • Cancer patients expected to undergo immunotherapy and/or radiation therapy

Exclusion Criteria:

  • Under the age of 18
  • Pregnant women
  • Women who are breastfeeding
  • Individuals with known or suspected substance abuse
  • Individuals unable or unwilling to comply with the study procedures
Contacts and Locations
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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): NCT03142204


Contacts
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Contact: Robert R Flavell, M.D., Ph.D. 917-509-8679 robert.flavell@ucsf.edu
Contact: Henry VanBrocklin, Ph.D. 415-353-4569 henry.vanbrocklin@radiology.ucsf.edu

Locations
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United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Maya Aslam    415-514-8987    maya.aslam@ucsf.edu   
Contact: Katherine Wu    415-353-9437    katherine.wu@ucsf.edu   
Sponsors and Collaborators
CellSight Technologies, Inc.
UCSF Imaging Center at China Basin
Investigators
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Principal Investigator: Robert R Flavell, M.D., Ph.D. UCSF Department of Radiology & Biomedical Imaging
More Information
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Responsible Party: CellSight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03142204    
Other Study ID Numbers: 14-14488
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No