TY - JOUR
T1 - Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma
T2 - multicenter phase III trials
AU - Wakabayashi, Toshihiko
AU - Hirose, Yuichi
AU - Miyake, Keisuke
AU - Arakawa, Yoshiki
AU - Kagawa, Naoki
AU - Nariai, Tadashi
AU - Narita, Yoshitaka
AU - Nishikawa, Ryo
AU - Tsuyuguchi, Naohiro
AU - Fukami, Tadateru
AU - Sasaki, Hikaru
AU - Sasayama, Takashi
AU - Kondo, Akihide
AU - Iuchi, Toshihiko
AU - Matsuda, Hiroshi
AU - Kubota, Kazuo
AU - Minamimoto, Ryogo
AU - Terauchi, Takashi
AU - Nakazato, Yoichi
AU - Kubomura, Kan
AU - Wada, Masatoshi
N1 - Funding Information:
The authors are indebted to Dr. Yoshio Uchino (Chiba Ryogo Center, National Agency for Automotive Safety and Victims’ Aid), Dr. Seishi Jinnouchi (Atsuchi Memorial Clinic PET Center), Dr. Yasushi Takagi (Showa University School of Medicine), and Dr. Keiichi Matsumoto (Kyoto College of Medical Science) for their advice as medical experts during the study. The authors also thank Dr. Yuzo Terakawa and Dr. Kazuhiro Yamanaka (Department of Neurosurgery, Osaka City University Graduate School of Medicine) for their co-operation during the study. We also would like to express our gratitude to the subjects, clinical research coordinators, radiological technologists and investigators who were involved in this study. The authors would also like to thank Go Kuratomi, PhD, of inScience Communications, Springer Healthcare for his support during preparation of the outline, and Nishad Parkar, PhD, of inScience Communications, Springer Healthcare for writing the abstract and English editing and styling the manuscript. This medical writing assistance was funded by Nihon Medi-Physics Co., Ltd.
Funding Information:
The authors are indebted to Dr. Yoshio Uchino (Chiba Ryogo Center, National Agency for Automotive Safety and Victims? Aid), Dr. Seishi Jinnouchi (Atsuchi Memorial Clinic PET Center), Dr. Yasushi Takagi (Showa University School of Medicine), and Dr. Keiichi Matsumoto (Kyoto College of Medical Science) for their advice as medical experts during the study. The authors also thank Dr. Yuzo Terakawa and Dr. Kazuhiro Yamanaka (Department of Neurosurgery, Osaka City University Graduate School of Medicine) for their co-operation during the study. We also would like to express our gratitude to the subjects, clinical research coordinators, radiological technologists and investigators who were involved in this study. The authors would also like to thank Go Kuratomi, PhD, of inScience Communications, Springer Healthcare for his support during preparation of the outline, and Nishad Parkar, PhD, of inScience Communications, Springer Healthcare for writing the abstract and English editing and styling the manuscript. This medical writing assistance was funded by Nihon Medi-Physics Co., Ltd.
Publisher Copyright:
© 2021, The Japanese Society of Nuclear Medicine.
PY - 2021/12
Y1 - 2021/12
N2 - Objective: Glioma is the most common type of central nervous system tumor reported worldwide. Current imaging technologies have limitations in the diagnosis and assessment of glioma. The present study aimed to confirm the diagnostic efficacy and safety of anti-1-amino-3-[18F]fluorocyclobutane carboxylic acid (18F-fluciclovine; anti-[18F]FACBC) as a radiotracer for patients undergoing combined positron emission tomography and computed tomography (PET/CT) for suspected glioma. Methods: Combined data from two multicenter, open-label phase III clinical trials were evaluated for this study. The two trials enrolled patients with suspected high- or low-grade glioma on the basis of clinical symptoms, clinical course, and magnetic resonance imaging findings, and who were scheduled for tumor resection surgery. Patients fasted for ≥ 4 h and received 2 mL of 18F-fluciclovine (radioactivity dose 78.3–297.0 MBq), followed by a 10-min PET scan 10–50 min after injection. The primary efficacy endpoint was the positive predictive value (PPV) of the gadolinium contrast-enhanced T1-weighted image negative [Gd (–)] and 18F-fluciclovine PET-positive [PET (+)] area of the scans, using the histopathological diagnosis of the tissue sampled from that area as the standard of truth. All adverse events reported during the study were recorded for safety analysis. Results: A total of 45 patients aged 23–89 years underwent 18F-fluciclovine PET; 31/45 patients (68.9%) were male, and 30/45 patients (66.7%) were suspected to have high-grade glioma. The PPV of 18F-fluciclovine PET in the Gd (–) PET (+) area was 88.0% (22/25 areas, 95% confidence interval: 70.0–95.8). The extent of planned tumor resection was modified in 47.2% (17/36 cases) after 18F-fluciclovine PET scan, with an extension of area in 30.6% (11/36 cases) and reduction in 16.7% (6/36 cases). Furthermore, tissue samples collected from PET (+) areas tended to have a higher malignancy grade compared with those from PET (–) areas. Overall, 18F-fluciclovine was well tolerated. Conclusion: 18F-fluciclovine PET/CT is useful for determining the extent of tumor resection at surgical planning, and may serve as a safe and effective diagnostic tool for patients with suspected glioma. Trial Registration: These trials were registered in the Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI-152986, JapicCTI-152985).
AB - Objective: Glioma is the most common type of central nervous system tumor reported worldwide. Current imaging technologies have limitations in the diagnosis and assessment of glioma. The present study aimed to confirm the diagnostic efficacy and safety of anti-1-amino-3-[18F]fluorocyclobutane carboxylic acid (18F-fluciclovine; anti-[18F]FACBC) as a radiotracer for patients undergoing combined positron emission tomography and computed tomography (PET/CT) for suspected glioma. Methods: Combined data from two multicenter, open-label phase III clinical trials were evaluated for this study. The two trials enrolled patients with suspected high- or low-grade glioma on the basis of clinical symptoms, clinical course, and magnetic resonance imaging findings, and who were scheduled for tumor resection surgery. Patients fasted for ≥ 4 h and received 2 mL of 18F-fluciclovine (radioactivity dose 78.3–297.0 MBq), followed by a 10-min PET scan 10–50 min after injection. The primary efficacy endpoint was the positive predictive value (PPV) of the gadolinium contrast-enhanced T1-weighted image negative [Gd (–)] and 18F-fluciclovine PET-positive [PET (+)] area of the scans, using the histopathological diagnosis of the tissue sampled from that area as the standard of truth. All adverse events reported during the study were recorded for safety analysis. Results: A total of 45 patients aged 23–89 years underwent 18F-fluciclovine PET; 31/45 patients (68.9%) were male, and 30/45 patients (66.7%) were suspected to have high-grade glioma. The PPV of 18F-fluciclovine PET in the Gd (–) PET (+) area was 88.0% (22/25 areas, 95% confidence interval: 70.0–95.8). The extent of planned tumor resection was modified in 47.2% (17/36 cases) after 18F-fluciclovine PET scan, with an extension of area in 30.6% (11/36 cases) and reduction in 16.7% (6/36 cases). Furthermore, tissue samples collected from PET (+) areas tended to have a higher malignancy grade compared with those from PET (–) areas. Overall, 18F-fluciclovine was well tolerated. Conclusion: 18F-fluciclovine PET/CT is useful for determining the extent of tumor resection at surgical planning, and may serve as a safe and effective diagnostic tool for patients with suspected glioma. Trial Registration: These trials were registered in the Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI-152986, JapicCTI-152985).
KW - F-fluciclovine
KW - Glioma
KW - Phase III trial
KW - Positron emission tomography
KW - Surgical planning
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UR - http://www.scopus.com/inward/citedby.url?scp=85112814809&partnerID=8YFLogxK
U2 - 10.1007/s12149-021-01670-z
DO - 10.1007/s12149-021-01670-z
M3 - Article
C2 - 34406623
AN - SCOPUS:85112814809
SN - 0914-7187
VL - 35
SP - 1279
EP - 1292
JO - Annals of Nuclear Medicine
JF - Annals of Nuclear Medicine
IS - 12
ER -