"Brain metastases occur in up to 40% of patients with cancer, and approximately 200,000 patients in the United States are affected by brain tumors each year," said Samuel T. Chao, MD, Department of Radiation Oncology, Cleveland Clinic; Professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; and Coordinating Investigator on the REVELATE Phase 3 study. "Due to the severity of disease, accurate and timely evaluation of the presence or absence of recurrent disease is essential for informing treatment decisions, as well as facilitating much-needed research into effective therapies for these patients. Conventional magnetic resonance imaging (MRI) is considered the "gold standard" for patient follow-up, but is unable to reliably differentiate recurrent disease from necrotic (dead) tissue which can result from radiation therapy. This can present challenges for physicians in determining appropriate patient management and care. The Phase 3 REVELATE clinical study is designed to investigate the diagnostic performance of 18F-fluciclovine PET imaging as a potential decision-making aid in assessing a patient's disease status, and we look forward to seeing the results of this clinical study."

"Guidelines and recommendations established by the Response Assessment in Neuro-Oncology (RANO) group recognize the limitations of conventional MRI. Recent recommendations in 2019 cite the potential utility of amino acid PET radiopharmaceuticals in distinguishing brain tissue changes after radiation therapy from recurrent brain metastases, while noting that data have been derived mainly from single center, retrospective studies. Consequently, a call for prospective multi-center studies has been re-iterated to validate these observations," said Peter Gardiner, MB ChB, MRCP, FFPM, Chief Medical Officer of Blue Earth Diagnostics. "In addition to its proven performance in the detection and localization of recurrent prostate cancer and, based on its mechanism of action, 18F-fluciclovine holds potential clinical utility for the detection of other cancers. Being an amino acid-based PET radiopharmaceutical, 18F-fluciclovine is designed to visualize the increased amino acid transport that occurs in malignant tumors, including in brain metastases that can recur after radiation therapy. The preferential uptake of 18F-fluciclovine into cancer cells should enable this recurrent disease to be reliably detected."

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