Blue Earth Diagnostics announces results from investigational clinical study of safety and effectiveness of 18F-Fluciclovine PET
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Blue Earth Diagnostics announces results from investigational clinical study of safety and effectiveness of 18F-Fluciclovine PET

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BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced results from a retrospective, observational analysis evaluating the safety and effectiveness of 18F-fluciclovine in the detection of recurrent gliomas in adults, using data from multiple research sites. The primary aim was to determine the Positive Predictive Value (PPV) of 18F-fluciclovine PET to detect glioma in comparison to a histopathological truth standard. Results demonstrated that among the patients with recurrent glioma (n=17), 18F-fluciclovine PET demonstrated a PPV of 88.2%, a detection rate of 100% and sensitivity of 100%. No adverse events related to 18F-fluciclovine were reported in the study. 18F-fluciclovine is a synthetic amino acid labeled with the radioisotope F 18, enabling PET imaging which may help visualize the increased amino acid transport that occurs in malignant brain tumors such as glioma.

Results of the study were announced in an oral presentation, “Safety and effectiveness of 18F-fluciclovine PET in adults with recurrent glioma: a retrospective observational study,” by Tore Bach-Gansmo, MD, PhD, Oslo University Hospital, Oslo, Norway, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, June 22 – 26, 2019 in Anaheim, Ca.

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“We are pleased to share results from this retrospective study of 18F-fluciclovine PET imaging of recurrent adult glioma with the nuclear medicine community at SNMMI,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “Clinical investigations such as this can help to inform the development of innovative PET imaging agents to address important unmet medical needs.”

“Glioma is a serious and potentially life-threatening disease, accounting for 80% of all malignant primary brain tumors,” said Peter Gardiner, MB ChB, MRCP, FFPM, CMO of Blue Earth Diagnostics. “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.”

In another oral presentation at SNMMI, “Evaluation of glioma tumor volume with 18F-fluciclovine positron emission tomography interpreted in combination with MRI, compared with MRI alone: Results from a prospective phase 3 blinded image evaluation,” Matthew Miller, PhD, of Blue Earth Diagnostics, presented results from another of the company’s clinical trials. The study, BED006, was a prospective, blinded image evaluation that 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% (n=35) for each of the three blinded readers and consistent image interpretation across these readers. In addition, 18F-fluciclovine PET with MRI (CE-T1W MRI) identified additional regions suspicious for glioma that CE-T1W MRI alone was unable to identify, which subsequent biopsies confirmed as malignant. To date, the safety profile of 18F-fluciclovine PET imaging in patients with glioma appears to be consistent with that summarized in current Axumin® U.S. prescribing information.
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