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

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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.

Tracking Information
First Submitted Date  ICMJE May 1, 2017
First Posted Date  ICMJE May 5, 2017
Last Update Posted Date December 5, 2022
Actual Study Start Date  ICMJE May 1, 2017
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • 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 scans will be performed at up to 4 different consecutive time points the day of the intravenous injection of the PET tracer. Up to four whole-body images will be obtained that will reveal biodistribution of [18F]F-AraG at up to 4 different consecutive time points on the day of the intravenous injection.
  • 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 scans will be performed at up to 4 different consecutive time points the day of the intravenous injection of the PET tracer. Up to four whole-body images will be obtained that will reveal biodistribution of [18F]F-AraG at up to 4 different consecutive time points on the day of the intravenous injection.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cancer
Intervention  ICMJE Drug: [18F]F-AraG
Single dose IV injection of [18F]F-AraG for each imaging day.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03142204
Other Study ID Numbers  ICMJE 14-14488
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party CellSight Technologies, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CellSight Technologies, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE UCSF Imaging Center at China Basin
Investigators  ICMJE
Principal Investigator: Robert R Flavell, M.D., Ph.D. UCSF Department of Radiology & Biomedical Imaging
PRS Account CellSight Technologies, Inc.
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP