About the Retrospective Observational Study in Adults with Glioma (BED008)
Study BED008 was a retrospective observational study of 18F-fluciclovine PET that was designed to evaluate the safety and efficacy of 18F-fluciclovine PET in the detection or recurrent gliomas in adults. It analyzed results from three clinical sites (Emory University, Atlanta, Ga., Memorial Sloan Kettering Cancer Center, New York, NY; and under a compassionate use program at Oslo University Hospital, Oslo, Norway). The primary objective of the study was to determine the Positive Predictive Value (PPV) of 18F-fluciclovine PET to detect glioma in comparison to a histopathological truth standard. Secondary objectives included determination of the detection rate, sensitivity, specificity, and negative predictive value (NPV). The study also aimed to evaluate adverse events in any patient who received 18F-fluciclovine.
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A total of 82 adult patients received at least one injection of 18F-fluciclovine for the detection or primary or recurrent glioma and had had at least one histopathological report confirming the diagnosis of glioma. Only patients whose 18F-fluciclovine PET scan, MRI and histopathology assessment (positive or negative) occurred within 30 days of one another were included in analyses of diagnostic performance. Eighteen of the 82 scans met these criteria (1 scan in a patient with primary glioma and 17 scans in patients with recurrent disease). Among the 17 patients with recurrent glioma, 18F-fluciclovine showed a PPV of 88.2%, a detection rate of 100% and sensitivity of 100%. In patients with recurrent high-grade glioma (n = 12), the PPV, detection rate and sensitivity were 83.3%, 100% and 100%, respectively. In patients with recurrent low-grade glioma (n = 5) these were 100%, 100% and 100%, respectively. Specificity and NPV could not be calculated as no patients had a negative 18F-fluciclovine PET scan. In total, 3.7% (3/82) patients experienced at least one treatment emergent adverse event during the safety monitoring, none of which were considered related to 18F-fluciclovine.
Glioma, the most commonly occurring type of primary brain tumor, is a serious and life-threatening condition. Cancer of the brain and central nervous system (CNS) is the twelfth most common cause of cancer death worldwide. Glioma accounts for about 25% of all brain tumors, and 80% of all malignant brain tumors. The most aggressive form of glioma, glioblastoma multiforme, is associated with significant morbidity and mortality with relatively low 5-year survival estimates after diagnosis. Current treatment options for patients with glioma include surgery, radiation and chemotherapy. Accurate evaluation of the location and extent of a glioma tumor is essential before or during surgery and radiotherapy and in assessing the continuing status of the disease. The detection and assessment of gliomas typically involves magnetic resonance imaging (MRI), which may be complemented by metabolic imaging using an appropriate amino acid-based PET radiopharmaceutical as recommended in the Response Assessment in Neuro-Oncology (RANO) working group and European Association for Neuro-Oncology (EANO) guidelines.