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

نویسندگان

  • Hiroshi Matsuda Integrative Brain Imaging Center, National Center of Neurology and Psychiatry
  • Kan Kubomura Clinical Development Department, Nihon Medi-Physics Co., Ltd.
  • Kazuo Kubota Division of Nuclear Medicine, Department of Radiology, National Center for Global Health and Medicine
  • Keisuke Miyake Department of Neurological Surgery, Faculty of Medicine, Kagawa University
  • Kimiteru Ito Department of Radiology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
  • Naoya Hashimoto Department of Neurosurgery, Osaka University Graduate School of Medicine
  • Osamu Okuda Department of Neurosurgery, Juntendo Tokyo Koto Geriatric Medical Center
  • Ryo Nishikawa Department of Neuro-Oncology/Neurosurgery, Saitama International Medical Center, Saitama Medical University
  • Tadashi Nariai Department of Neurosurgery, Tokyo Medical and Dental University
  • Takashi Sasayama Department of Neurosurgery, Kobe University Graduate School of Medicine
  • Yoshiki Arakawa Department of Neurosurgery, Kyoto University Graduate School of Medicine
  • Yoshitaka Narita Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital
چکیده مقاله:

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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عنوان ژورنال

دوره 5  شماره 1

صفحات  10- 21

تاریخ انتشار 2017-01-01

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