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Annals of Nuclear Medicine (2018) 32:217–235
https://doi.org/10.1007/s12149-018-1230-7
REPORT
Manual on the proper use of lutetium-177-labeled somatostatin
analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd
ed.)
Makoto Hosono
1
· Hideharu Ikebuchi
2
· Yoshihide Nakamura
3
· Nobutaka Nakamura
3
· Takahiro Yamada
3
·
Sachiko Yanagida
3
· Asami Kitaoka
3
· Kiyotaka Kojima
4
· Hiroyasu Sugano
4
· Seigo Kinuya
2
· Tomio Inoue
2
·
Jun Hatazawa
2
Received: 6 January 2018 / Accepted: 8 January 2018 / Published online: 15 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 conjunc-
tion with the use of a lutetium-177 (Lu-177)-labeled somato-
statin 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
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 Medi-
cal Safety Bureau”) [1], which was superseded by “Release
of Patients who have been Administered a Radiopharmaceu-
tical” (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 neuroendocrine tumors of the
pancreas or gastrointestinal tract express high levels of
somatostatin receptors. Phase I and II clinical trials of the
labeled somatostatin analogue have recently been conducted
overseas, and the results of those trials have indicated that
the labeled somatostatin analogue has satisfactory antitumor
action and improves QOL [3–5], as shown in Table 1.
Nevertheless, the labeled somatostatin analogue must be
administered at a dose of 7400 MBq × 4 (at an interval of
about 8 weeks) [6] for the therapy to have a marked thera-
peutic benefit. Thus, medical personnel who perform the
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
hosono@med.kindai.ac.jp
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
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