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
- Study HIC#:2000028546
- Last Updated:01/01/0001
An open-label, single dose, single arm, 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
- Age18 years and older
For more information about this study, including how to volunteer, contact:
- Phone Number: 1-203-785-3852
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Trial Purpose and Description
Primary Outcome Measures :
- Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
- Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
- Previous history of solid tumor brain metastasis of any origin
- Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
- Previous radiation therapy of brain metastatic lesion(s)
- A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
- Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC
1. Patients with a history of active hematological malignancy