An Open-label Single-arm Single-dose Prospective Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases after Radiation Therapy (PURSUE) | NYU Langone Health

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An Open-label Single-arm Single-dose Prospective Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases after Radiation Therapy (PURSUE)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Brain Metastases
Age: Between 18 years - 100 years
Gender: Male or Female

Other Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 2. Previous history of solid tumor brain metastasis of any origin. 3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years of Screening (Visit 1). 4. Previous radiation therapy of brain metastatic lesion(s) completed at least 8 weeks before Screening.

You may not be eligible for this study if the following are true:

1. Pregnant or breastfeeding during participation in the study, or, where applicable, unwilling to abstain from sexual conduct for 24 hours post-18F-fluciclovine injection. 2. Subjects with active hematological malignancy.