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An Investigational Scan ([18F]F AraG PET) for Monitoring Response to Checkpoint Inhibitor Therapy in Patients with Solid Tumors
Trial Status: active
This phase II trial tests whether [18F]F AraG positron emission tomography (PET) works in monitoring tumor response to checkpoint inhibitor chemotherapy (CkIT) in patients with solid tumors undergoing checkpoint inhibitor therapy. [18F]F AraG is a radioactive molecule, called a "radiotracer," that binds to certain cells in the immune system. When [18F]F AraG is injected into the blood, researchers are able to see where immune cells are working using a special scanner called a PET scanner. The PET scanner works by detecting the radioactive substance inside the body and making images that show where the radiation is concentrated. Diagnostic procedures, such as [18F]F AraG PET, may help measure a patient's response to checkpoint inhibitor therapy.
Inclusion Criteria
Patients with solid malignancy with CkIT planned as part of their anticancer therapy (Other concurrent therapies are allowed)
Patient >= 18 years old
Documented written informed consent
A review of prior imaging studies of the patient computed tomography (CT) or magnetic resonance imaging (MR) within 6 months prior to study enrollment. The patient must have two (2) eligible lesions for F-AraG positron emission tomography (PET) imaging and biopsy: at least one lesion must be > 1 cm diameter in short axis, and another should be biopsiable.
Exclusion Criteria
Patient is pregnant or breast feeding
Patients requiring general anesthesia for their research biopsy
Additional locations may be listed on ClinicalTrials.gov for NCT04260256.
I. To correlate change in fluorine F 18 Ara-G ([18F]F AraG) signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies.
SECONDARY OBJECTIVES:
I. Correlate change in [18F]F AraG uptake signal in tumor lesions with clinical benefit rate (defined as complete response [CR] + partial response [PR] + stable disease > 4 months) using Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
II. Correlate change in [18F]F AraG signal in lung and gastrointestinal (GI) tract with the occurrence of grade 3 or 4 immune related adverse events.
OUTLINE:
Patients receive [18F]F AraG intravenously (IV) and undergo PET/computed tomography (CT) at baseline (up to 14 days before start of CkIT therapy) and up to 6 weeks after day 1 of CkIT therapy. Patients also undergo biopsies prior to and after treatment completion on study.
After completion of study intervention, patients are followed up every 3 months for up to 12 months or until the time of disease progression.
