Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.
PRIMARY OBJECTIVES:
I. To determine if FET 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 (Combined populations)
SECONDARY OBJECTIVES:
I. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.(Combined populations).
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.(Combined populations).
III. To assess the safety of FET PET, as determined by treatment emergent adverse events (TEAEs) within 48 hours of FET administration.(Combined populations).
IV. To describe the inter-reader variability between 3 independent blinded readers of FET PET images in assessments of benign TRC versus recurrent glioma.(Combined populations).
V. To describe intra-reader variability between 3 independent blinded readers of FET PET images in the assessments of benign TRC versus recurrent glioma.(Combined populations).
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 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 (Population 2).
OUTLINE:
Participants receive F-18 fluoroethyltyrosine intravenously (IV) over approximately 1 minute and undergo PET over 40 minutes. After completion of study treatment, participants are followed up periodically.
Inclusion Criteria:
Age > 3 years.
Presence or suspicion of intracranial neoplasm in two populations.
Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered:
Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.
Exclusion Criteria:
Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.