Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm

PRIMARY OBJECTIVES:

• To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas.
• To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2.

SECONDARY OBJECTIVES:

• To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1.
• To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.

EXPLORATORY OBJECTIVES:

• To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas.

OUTLINE:

Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET. Adult participants may undergo up to two repeat FET PET scans. Adverse events will be recorded.

Inclusion criteria

• Presence or suspicion of intracranial neoplasm in two populations:

• Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.
• Three sub-populations will be considered:

• Recurrent metastatic lesions.
• Recurrent high-grade gliomas (Grades 3 and 4).
• Recurrent low-grade gliomas (Grade 2).
• Population 2: Participants prior to primary treatment with planned biopsy or surgical resection.
• Age > 3 years.

Participants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.

Exclusion criteria

• Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.
• Participants unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

• Sedation or anesthesia can be used for participants who cannot tolerate the exam.