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

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 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration (i.e. drop to a performance status of 2, within 4 weeks of Screening). 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. Form of radiotherapy may include stereotactic radiosurgery or whole brain radiotherapy.

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.


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