diagnostic performance and safety of positron emission tomography using 18f-fluciclovine in patients with clinically suspected high- or low-grade gliomas: a multicenter phase iib trial

objective(s): the study objective was to assess the diagnostic performance of positron emission tomography (pet) for gliomas using the novel tracer 18f-fluciclovine (anti-[18f]facbc) and to evaluate the safety of this tracer in patients with clinically suspected gliomas.methods: anti-[18f]facbc was administered to 40 patients with clinically suspected high- or low-grade gliomas, followed by pet imaging. t1-weighted, contrast-enhanced t1-weighted, and fluid-attenuated inversion recovery (or t2-weighted) magnetic resonance imaging (mri) scans were obtained to plan for the tissue collection. tissues were collected from either “areas visualized using anti-[18f]facbc pet imaging but not using contrast-enhanced t1-weighted imaging” or “areas visualized using both anti-[18f]facbc-pet imaging and contrast-enhanced t1-weighted imaging” and were histopathologically examined to assess the diagnostic accuracy of anti-[18f]facbc-pet for gliomas.results: the positive predictive value of anti-[18f]facbc-pet imaging for glioma in areas visualized using anti-[18f]facbc-pet imaging, but not visualized using contrast-enhanced t1- weighted images, was 100.0% (26/26), and the value in areas visualized using both contrastenhanced t1-weighted imaging and anti- [18f]facbc-pet imaging was 87.5% (7/8). twelve adverse events occurred in 7 (17.5%) of the 40 patients who received anti-[18f]facbc. five events in five patients were considered to be adverse drug reactions; however, none of the events were serious, and all except one resolved spontaneously without treatment.conclusion: this phase iib trial showed that anti-[18f]facbc-pet imaging was effective for the detection of gliomas in areas not visualized using contrast-enhanced t1-weighted mri and the tracer was well tolerated.