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NCT03142204 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03142204
Other study ID # 14-14488
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 1, 2017
Est. completion date May 2024

Study information
Verified date December 2022
Source CellSight Technologies, Inc.
Contact Robert R Flavell, M.D., Ph.D.
Phone 917-509-8679
Email robert.flavell@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• [18F]F-AraG
Single dose IV injection of [18F]F-AraG for each imaging day.

Locations
Country Name City State
United States UCSF Imaging Center at China Basin San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
CellSight Technologies, Inc. UCSF Imaging Center at China Basin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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