[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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03142204

Enrollment

Registered

2017-05-05

Start date

2017-05-01

Completion date

2024-05-31

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUG[18F]F-AraG

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactRobert R Flavell, M.D., Ph.D.

robert.flavell@ucsf.edu917-509-8679

Backup ContactHenry VanBrocklin, Ph.D.

henry.vanbrocklin@radiology.ucsf.edu415-353-4569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026