Patient Enrollment Complete for Phase 3 18F-Fluciclovine PET Imaging of Recurrent Brain Mets

Blue Earth Diagnostics, a Bracco company, announced completion of patient accrual in its Phase 3 REVELATE clinical trial of¹⁸F-fluciclovine, a positron emission tomography (PET) imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases after radiotherapy. The REVELATE study is a prospective Phase 3, multi-center, single-arm imaging study being conducted in the United States.¹⁸F-fluciclovine is an approved molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. 

“Expanding our ¹⁸F-fluciclovine franchise into neuro-oncology is part of the overall growth strategy for Blue Earth Diagnostics, and completion of Phase 3 patient accrual sets a major milestone in our development plan,” said David E. Gauden, DPhil, Chief Executive Officer. “We look forward to receiving the clinical results from REVELATE, and to presenting results of the Phase 2 PURSUE study at upcoming scientific meetings later this year. Additionally, we wish to thank the patients, physicians and clinical trial sites who worked closely with us to complete enrollment despite the many challenges presented by the COVID-19 pandemic. In line with our mission to develop novel PET radiopharmaceuticals to inform the management and care of patients with cancer, we are hopeful that our efforts may help patients with recurrent metastatic brain cancer.”

“Radiation therapy is a mainstay of treatment for brain metastases which provides effective tumor control but can result in radiation necrosis,” 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. “Serial magnetic resonance imaging (MRI) is often used to monitor patients after treatment. However, physicians face challenges in diagnosing and managing suspicious lesions found upon post-treatment surveillance, as they may represent tumor recurrence or treatment-related changes such as radiation necrosis. Significant progress has been made in diagnostic imaging modalities to assist in differentiating these entities, among them the use of amino acid-based PET radiopharmaceuticals. The Phase 3 REVELATE trial is designed to investigate the diagnostic performance of amino acid ¹⁸F-fluciclovine PET imaging as a potential decision-making aid in assessing the status of a patient’s disease.”

“Limitations of conventional MRI are recognized in guidelines and recommendations established by the Response Assessment in Neuro-Oncology (RANO) group. Recommendations from the RANO/PET working group in 2019 cite the potential utility of amino acid PET radiopharmaceuticals in distinguishing brain tissue changes after radiation therapy from recurrent brain metastases. In noting that existing data have been derived mainly from single center, retrospective studies, a call for prospective multi-center studies has been re-iterated to validate these observations,” said Eugene J. Teoh, MBBS, MRCP, FRCR, DPhil, Chief Medical Officer of Blue Earth Diagnostics. “¹⁸F-Fluciclovine holds potential clinical utility for the detection of other cancers besides recurrent prostate cancer. As an amino acid-based PET radiopharmaceutical, ¹⁸F-fluciclovine is designed to visualize the increased amino acid transport that occurs in malignant tumors and we eagerly await the results of the REVELATE and PURSUE clinical trials.”

The Phase 2 PURSUE trial is designed to establish image interpretation criteria for¹⁸F-fluciclovine PET in detecting recurrent brain metastases.