[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
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Cancer

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