Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide the
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Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd ed.) Makoto Hosono1 · Hideharu Ikebuchi2 · Yoshihide Nakamura3 · Nobutaka Nakamura3 · Takahiro Yamada3 · Sachiko Yanagida3 · Asami Kitaoka3 · Kiyotaka Kojima4 · Hiroyasu Sugano4 · Seigo Kinuya2 · Tomio Inoue2 · Jun Hatazawa2 Received: 6 January 2018 / Accepted: 8 January 2018 © The Author(s) 2018. This article is an open access publication
Abstract Here we present the guideline for the treatment of neuroendocrine tumors using Lu-177-DOTA-TATE on the basis of radiation safety aspects in Japan. This guideline was prepared by a study supported by Ministry of Health, Labour, and Welfare, and approved by Japanese Society of Nuclear Medicine. Lu-177-DOTA-TATE treatment in Japan should be carried out according to this guideline. Although this guideline is applied in Japan, the issues for radiation protection shown in this guideline are considered internationally useful as well. Only the original Japanese version is the formal document. Keywords Lu-177-DOTA-TATE · Radionuclide therapy · Neuroendocrine tumor
Goals of radiation safety management This Manual covers radiation safety management in conjunction with the use of a lutetium-177 (Lu-177)-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable (denoted here as “the labeled somatostatin analogue”) to treat an unresectable or metastatic neuroendocrine tumor (denoted here as “therapy with the labeled somatostatin analogue”), and this Manual was compiled to comply with principles of safety guidelines related to “Release of Patients who have This Manual was produced by a research group that was awarded a Grant from the Ministry of Health, Labour and Welfare, and was approved by Japanese Society of Nuclear Medicine on May 20, 2016. * Makoto Hosono [email protected] 1
Faculty of Medicine, Kindai University, 377‑2 Ohno‑Higashi, Osaka‑Sayama, Osaka 589‑8511, Japan
2
Japanese Society of Nuclear Medicine, 2‑28‑45 Honkomagome, Bunkyo‑ku, Tokyo 113‑0021, Japan
3
Japan Radioisotope Association, 2‑28‑45 Honkomagome, Bunkyo‑ku, Tokyo 113‑0021, Japan
4
FUJIFILM RI Pharma Co., Ltd., 2‑14‑1 Kyobashi, Chuo‑Ku, Tokyo 104‑0031, Japan
been Administered a Radiopharmaceutical” (Notice No. 70 from the Safety Division, Pharmaceutical and Medical Safety Bureau dated June 30, 1998, denoted here as “Notice No. 70 from the Safety Division, Pharmaceutical and Medical Safety Bureau”) [1], which was superseded by “Release of Patients who have been Administered a Radiopharmaceutical” (Notice No. 1108-2 from the Division for Guidance on Medical Care, Health Policy Bureau dated November 8, 2010, denoted here as “Notice No. 1108-2 from the Division for Guidance on Medical Care, Health Policy Bureau”) [2] issued by the Ministry of Health, Labour, and Welfare. This Manual was also compiled to ensure the safe handling of the labeled somatostatin analogue. Unresectable or metastatic neuroendocrine tumors often have a poor prognosis, and neuro
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