Thirty-five 18F-fluciclovine PET and MRI (CE-T1W and FLAIR [or T2W]) image datasets with corresponding histopathological standard-of-truth data collected from patients who received 18F-fluciclovine for the imaging of suspected glioma in a previously conducted, prospective Phase 2 clinical trial (JapicCTI-132289) were evaluated. Three independent, blinded readers assessed images captured by cranial PET scan, a mean of 13.1 minutes after the injection of 18F-fluciclovine. Reader reproducibility was assessed by determining agreement in diagnostic performance parameters.

Results demonstrated the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with MRI, with a PPV of more than 90% for each of the three readers, regardless of whether images were positive or negative on MRI. The sensitivity of 18F-fluciclovine with MRI (CE-T1W MRI) (range 65.8 - 71.1%) was shown to be higher than that of MRI alone (CE-T1W MRI) (42.1%) but not as high as FLAIR (or T2W) MRI alone (86.8%). The 88.9% specificity of 18F-fluciclovine with MRI (CE-T1W MRI) was equal to that of MRI (CE-T1W MRI) alone and higher than FLAIR (or T2W) MRI alone (33.3%). Agreement across readers indicated high concordance, with 89.4% of PET scans in agreement.


Blue Earth Diagnostics is pursuing regulatory filings for the use of 18F-fluciclovine PET imaging in adults for the detection and continuing assessment of the disease. The compound has been granted Orphan Drug status by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the diagnosis of glioma.


About 18F-fluciclovine PET in Glioma
18F-fluciclovine PET is a diagnostic imaging radiopharmaceutical for PET imaging that consists of a synthetic amino acid labeled with the radioisotope F 18, enabling the visualization of the increased amino acid transport that occurs in malignant tumors. 18F-fluciclovine, under the trade name Axumin®, is approved by the U.S. Food and Drug Administration (FDA) for PET imaging in men with biochemically recurrent prostate cancer. It is also under investigation by Blue Earth Diagnostics for use in adults for the detection and continuing assessment of glioma. 18F-fluciclovine has been granted Orphan Drug status by both the FDA and the European Medicines Agency for the diagnosis of glioma. The compound was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences.

Molecular Imaging Homepage