Clincosm LogoSign in Get a demo

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

Sponsor
CellSight Technologies, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03142204
Collaborator
UCSF Imaging Center at China Basin (Other)
30
Enrollment
1
Location
84
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy [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 [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 UCSF Imaging Center at China Basin San Francisco California United States 94107

Sponsors and Collaborators

  • CellSight Technologies, Inc.
  • UCSF Imaging Center at China Basin

Investigators

  • Principal Investigator: Robert R Flavell, M.D., Ph.D., UCSF Department of Radiology & Biomedical Imaging

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CellSight Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT03142204
Other Study ID Numbers:
  • 14-14488
First Posted:
May 5, 2017
Last Update Posted:
Aug 3, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 3, 2021