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

Phase 1

Recruiting

• Conditions: Cancer

• Registration Number: NCT03142204
• Lead Sponsor: CellSight Technologies, Inc.

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

UCSF Imaging Center at China Basin; 🇺🇸 San Francisco, California, United States