This phase IV trial studies how well 18F-fluciclovine positron emission tomography (PET)/computed tomography (CT) works in diagnosing radiation necrosis versus tumor progression in patients with cancer that has spread to the brain (metastatic) following stereotactic radiosurgery. Radiation necrosis is damage that occurs to normal brain tissue caused by radiation and looks similar to a tumor that is growing, spreading, or getting worse (tumor progression) when viewed using magnetic resonance imaging (MRI). 18F-fluciclovine PET/CT may be able to distinguish radiation necrosis from tumor progression in cases where the MRI is inconclusive.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03930173.
PRIMARY OBJECTIVES:
I. The accuracy of fluciclovine F18 (18F-fluciclovine) PET in distinguishing radiation necrosis from tumor progression will be estimated via receiver operating characteristic curve analysis.
SECONDARY OBJECTIVES:
I. To assess which factors may influence accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression.
II. To estimate sensitivity and specificity.
III. To compare the accuracy of each of the qualitative and quantitative metrics of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression.
OUTLINE:
Patients receive fluciclovine F18 intravenously (IV) and then undergo a PET/CT scan over 25 minutes.
After completion of study, patients are followed up every 3 months for 1 year.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorSamuel Tay Chao
