This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in patients with intracranial tumors that have come back. Imaging agents, such as fluoroethyltyrosine, may help doctors see the tumor better during a positron emission tomography PET scan.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04044937.
PRIMARY OBJECTIVES:
I. To determine if fluoroethyltyrosine (FET) positron emission tomography (PET) can differentiate between benign treatment-related changes (TRC) and recurrent glioma in comparison to a composite standard of truth (CSOT) that includes pathology and other clinical information, evaluated using estimates of sensitivity and specificity.
SECONDARY OBJECTIVES:
I. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.
II. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a CSOT evaluated using estimates other than subject-based sensitivity and specificity.
III. To assess the safety of FET PET, as determined by treatment emergent adverse events (TEAEs) within 48 hours of FET administration.
IV. To describe the inter-reader variability between 3 independent blinded readers of FET PET images in their assessments of benign TRC versus recurrent glioma.
V. To describe intra-reader variability between 3 independent blinded readers of FET PET images in their assessments of benign TRC versus recurrent glioma.
EXPLORATORY OBJECTIVES:
I. To assess relationships between serial FET PET and clinical outcome (benign TRC and recurrence) in patients with recurrent metastatic lesions, recurrent high grade gliomas and recurrent low grade gliomas.
II. To determine if magnetic resonance imaging (MRI) can differentiate between benign treatment- related changes and recurrence.
III. To describe the distribution of the standardized uptake value (SUV) and tumor-to-background ratio (TBR) for observed lesions.
IV. To determine if FET PET can differentiate between benign TRC and recurrent metastatic lesions.
V. To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas in population 2.
OUTLINE:
Patients receive F-18 fluoroethyltyrosine intravenously (IV) over approximately 1 minute and undergo PET over 40 minutes. Adult patients may undergo an additional FET PET.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorThomas A. Hope
