An Open-label Single-arm Single-dose Prospective Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases after Radiation Therapy

Brief description of study

The purpose of the study is to determine the diagnostic performance of 18F-Fluciclovine Positron Emission Tomography (PET) in detecting recurrent brain metastases after radiation therapy. We want to know the safety of 18F-fluciclovine injection in the subject population and clinical usefulness of 18F-fluciclovine PET in evaluation of subjects with suspected recurrent brain metastases. The investigational product in this study is 18F-Fluciclovine injection, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s20-00310 Identifier: NCT04410133

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