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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: [18F]F-AraG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [18F]F-AraG|Single dose IV injection of [18F]F-AraG for each imaging day.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |