18F-Fluciclovine PET/CT to Distinguish Tumor Progression From Radiation Necrosis

Inclusion Criteria

• Subjects must have a confirmed diagnosis of brain metastases
• Subjects must have received prior intracranial stereotactic radiosurgery (SRS) at least once for brain metastases. Prior whole brain radiotherapy (WBRT) is allowed
• Subjects must have had a clinical tumor protocol magnetic resonance imaging (MRI) of the brain including a dynamic susceptibility contrast (DSC)-magnetic resonance (MR) perfusion sequence, which is equivocal for radiation necrosis versus tumor progression within 30 days of treatment scan. “Equivocal” will be defined as being inconclusive for radiation necrosis versus tumor progression as determined by the study neuroradiologist
• Physician assessed life expectancy of >= 6 months
• Subjects must have the ability to understand and the willingness to sign a written informed consent document
• For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required

Exclusion Criteria

• Subjects who have experienced a prior anaphylaxis reaction to 18F-fluciclovine are not eligible
• Females pregnant at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the fetus from exposure to radiation. Women who could be pregnant require a negative pregnancy test to be eligible
• Women who are breast feeding at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the infant from exposure to radiation
• Subjects contraindicated for MRI
• Subjects unable or unwilling to comply with study requirements are not eligible
• Major medical illness or psychiatric impairments, which in the investigator’s opinion, will prevent completion of protocol therapy and/or preclude informed consent
• Brain metastases from primary lymphoma, germ cell tumor, or small cell carcinoma