NCT03142204

[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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: CellSight Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	[18F]F-AraG	Single dose IV injection of \[18F\]F-AraG for each imaging day.

Timeline

• Start date: 2017-05-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2017-05-05
• Last updated: 2022-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study