“Glioma is a serious and potentially life-threatening disease, and the ability to identify the location and extent of a tumor is important in planning appropriate treatment for patients, in both initial diagnosis and subsequent monitoring for recurrence,” said Peter Gardiner, MB ChB, MRCP, FFPM, CMO of Blue Earth Diagnostics. “PET imaging provides additional insight beyond MRI into the biology and treatment response of gliomas1.”

“Guidelines from the Response Assessment in Neuro-Oncology (RANO) working group and the European Association for Neuro-Oncology (EANO) emphasize the clinical value of PET imaging with superiority of amino acid PET over glucose PET and provides a framework for the use of PET to assist in the management of patients with glioma1,” said Matthew P. Miller, PhD, Head of Imaging at Blue Earth Diagnostics and lead author on the BED006 study. “18F-fluciclovine is a synthetic amino acid taken up by certain cancer cells. This blinded image evaluation study examined the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with various types of MRI, for imaging of suspected glioma when interpreted by readers unfamiliar with 18F-fluciclovine PET. Results indicated a Positive Predictive Value (PPV) of more than 90% for each of the three blinded readers and consistent image interpretation across these readers. Additionally, 18F-fluciclovine PET with MRI (CE-T1W MRI) identified additional regions suspicious for glioma that MRI alone was unable to identify, which subsequent biopsies confirmed as malignant.”


About the Phase 3 Blinded Image Evaluation (BIE) Study in Glioma (BED006)

Study BED006 was a prospective, Phase 3, Blinded Image Evaluation (BIE) study of 18F-fluciclovine PET data sets derived from a previous prospective Phase 2 study, designed to evaluate the efficacy of 18F-fluciclovine PET combined with MRI imaging, as compared to MRI alone, in adults with glioma. The primary objective of the study was to determine the positive predictive value (PPV) of 18F-fluciclovine PET when combined with MRI (CE-T1W MRI), compared to MRI (CE-T1W MRI) alone. Secondary objectives included determining the diagnostic performance of 18F-fluciclovine PET and MRI compared with various types of MRI: CE-T1W MRI alone; fluid-attenuated inversion recovery (“FLAIR”) (or T2-weighted MRI) alone; and FLAIR (or T2W) MRI and CE-T1W MRI in combination. The study also assessed the reproducibility of interpretation of 18F-fluciclovine PET with MRI (CE-T1W MRI) image evaluation when interpreted by naïve readers.

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