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. 2017 Winter;5(1):10-21.
doi: 10.22038/aojnmb.2016.7869.

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  1 , Toshihiko Iuchi  2 , Naohiro Tsuyuguchi  3 , Ryo Nishikawa  4 , Yoshiki Arakawa  5 , Takashi Sasayama  6 , Keisuke Miyake  7 , Tadashi Nariai  8 , Yoshitaka Narita  9 , Naoya Hashimoto  10 , Osamu Okuda  11 , Hiroshi Matsuda  12 , Kazuo Kubota  13 , Kimiteru Ito  14 , Yoichi Nakazato  15 , Kan Kubomura  16
Affiliations

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 et al. Asia Ocean J Nucl Med Biol. 2017 Winter.

Abstract

Objectives: 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 contrast-enhanced 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.

Keywords: 18F-fluciclovine; Brain tumor; Clinical trial; Glioma; Positron-Emission Tomography.

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Figures

Figure 1
Figure 1
Patient characteristics. Forty-two subjects consented to participate in this study and were enrolled. Of these, 40 received anti-[18F]FACBC and were included in the safety analysis set. To assess the ability to visualize tumors using anti-[18F]FACBC-PET imaging, tissues were collected from 35 of the 40 patients who received anti-[18F]FACBC
Figure 2
Figure 2
Case H12 (suspected high-grade glioma). T1-weighted (A1), contrast-enhanced T1-weighted (A2 and A4 [Close up of tumor]), FLAIR (A3), and anti-[18F]FACBC-PET (A5 and A6 [Close up of tumor]) images of a patient in whom tissue collected from a Gd(-) PET(+) area was histopathologically diagnosed as infiltration of astrocytoma. The Ki-67 index was 8.9% and approximately 10% of cells were tumor cells. (Arrow and circle of each image indicate tumor lesion and tissue sampling site.)
Figure 3
Figure 3
Case L18 (suspected low-grade glioma). T1-weighted (A1/B1), contrast-enhanced T1-weighted (A2/B2 and A4/B4 [Close up of tumor]), T2 (A3/B3), and anti-[18F]FACBC-PET (A5/B5 and A6/B6 [Close up of tumor]) images of a patient in whom (A) tissue collected from a Gd(-) PET(+) area was diagnosed histopathologically as anaplastic astrocytoma (Ki-67 index, 35.1%; approximately 80% of cells were tumor cells), and (B) tissue collected from a Gd(-) PET(-) area was histopathologically diagnosed as non-tumor (Ki-67 index, 0.0%; approximately 0% of cells were tumor cells). (Arrow and circle on each image indicate tumor lesion and tissue sampling site.)
Figure 4
Figure 4
Case L07 (suspected low-grade glioma). T1-weighted (A1/B1), contrast-enhanced T1-weighted (A2/B2 and A4/B4 [Close up of tumor]), FLAIR (A3/B3), and anti-[18F]FACBC-PET (A5/B5 and A6/B6 [Close up of tumor]) images of a patient in whom (A) tissue collected from a Gd(-) PET(+) area was histopathologically diagnosed as oligodendroglioma (Ki-67 index, 9.7%; approximately 80% of cells were tumor cells) and (B) tissue collected from a Gd(-) PET(-) area was histopathologically diagnosed as infiltration of oligodendroglioma (Ki-67 index, 5.2%; approximately 5% of cells were tumor cells). (Arrow and circle of each image indicate tumor lesion and tissue sampling site.)
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