Asia Oceania Journal of Nuclear Medicine and Biology (Jan 2017)

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

  • Toshihiko Wakabayashi,
  • Toshihiko Iuchi,
  • Naohiro Tsuyuguchi,
  • Ryo Nishikawa,
  • Yoshiki Arakawa,
  • Takashi Sasayama,
  • Keisuke Miyake,
  • Tadashi Nariai,
  • Yoshitaka Narita,
  • Naoya Hashimoto,
  • Osamu Okuda,
  • Hiroshi Matsuda,
  • Kazuo Kubota,
  • Kimiteru Ito,
  • Yoichi Nakazato,
  • Kan Kubomura

DOI
https://doi.org/10.22038/aojnmb.2016.7869
Journal volume & issue
Vol. 5, no. 1
pp. 10 – 21

Abstract

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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.

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