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

NCT03142204 — Phase 1, Unknown, 30 participants, CellSight Technologies, Inc.

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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

Registry	NCT03142204
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	30 (Estimated)
Sponsor	CellSight Technologies, Inc. (Industry); collaborators: UCSF Imaging Center at China Basin
Conditions	Cancer
Interventions	[18F]F-AraG (Drug)
Dates	start 2017-05-01, primary completion 2024-05-01 (estimated), completion 2024-05-01 (estimated), first posted 2017-05-05, last updated 2022-12-05
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
UCSF Imaging Center at China Basin	San Francisco, California	United States	Recruiting

+Investigators

Robert R Flavell, M.D., Ph.D., Principal investigator, UCSF Department of Radiology & Biomedical Imaging

My Notes

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