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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: [18F]F-AraG

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Robert R Flavell, M.D., Ph.D.; Phone Number: 917-509-8679; Email: robert.flavell@ucsf.edu
• Study Contact Backup: Name: Henry VanBrocklin, Ph.D.; Phone Number: 415-353-4569; Email: henry.vanbrocklin@radiology.ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Recruiting
      • UCSF Imaging Center at China Basin
      • Contact: Maya Aslam; Phone Number: 415-514-8987; Email: Maya.Aslam@ucsf.edu
      • Contact: Katherine Wu; Phone Number: 415-353-9437; Email: katherine.wu@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy	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.	Up to 6 weeks before immunotherapy is administered
Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy	Whole-body [18F]F-AraG PET scan will be performed after intravenous injection of the PET tracer.	Up to 12 weeks after start of immunotherapy

Collaborators and Investigators

• Sponsor: CellSight Technologies, Inc.
• Collaborators: UCSF Imaging Center at China Basin
• Investigators: Principal Investigator: Robert R Flavell, M.D., Ph.D., UCSF Department of Radiology & Biomedical Imaging

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 14-14488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No