Skip to main content
Top
Published in: Annals of Nuclear Medicine 7/2021

01-07-2021 | Radiation Protection | Special Article

Manual on the proper use of sodium astatide ([211At]NaAt) injections in clinical trials for targeted alpha therapy (1st edition)

Authors: Tadashi Watabe, Makoto Hosono, Seigo Kinuya, Takahiro Yamada, Sachiko Yanagida, Masao Namba, Yoshihide Nakamura

Published in: Annals of Nuclear Medicine | Issue 7/2021

Login to get access

Abstract

We present the guideline for use of [211At] sodium astatide (NaAt) for targeted alpha therapy in clinical trials on the basis of radiation safety issues in Japan. This guideline was prepared by a study supported by the Ministry of Health, Labour, and Welfare, and approved by the Japanese Society of Nuclear Medicine on 8th Feb, 2021. The study showed that patients receiving [211At]NaAt do not need to be admitted to a radiotherapy room and outpatient treatment is possible. The radiation exposure from the patient is within the safety standards of the ICRP and IAEA recommendations for the general public and caregivers. Precautions for patients and their families, safety management associated with the use of [211At]NaAt, education and training, and disposal of medical radioactive contaminants are also included in this guideline. Treatment using [211At]NaAt in Japan should be carried out according to this guideline. Although this guideline is applied in Japan, the issues for radiation protection and evaluation methodology shown here are considered internationally useful as well.
Literature
1.
go back to reference Release of patients who have been administered a radiopharmaceutical (Notification No. 0511–1 by the Director of Medical Care Planning Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, dated May 11, 2016). Release of patients who have been administered a radiopharmaceutical (Notification No. 0511–1 by the Director of Medical Care Planning Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, dated May 11, 2016).
2.
go back to reference Release of patients who have been administered a radiopharmaceutical (Notification No. 70 by the Director of the Safety Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health, Labour and Welfare, dated June 30, 1998). Release of patients who have been administered a radiopharmaceutical (Notification No. 70 by the Director of the Safety Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health, Labour and Welfare, dated June 30, 1998).
3.
go back to reference Haugen BR, Alexander EK, Bible KC, et al. 2015 American thyroid association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer: the American thyroid association guidelines task force on thyroid nodules and differentiated thyroid cancer. Thyroid. 2016;26:1–133.CrossRef Haugen BR, Alexander EK, Bible KC, et al. 2015 American thyroid association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer: the American thyroid association guidelines task force on thyroid nodules and differentiated thyroid cancer. Thyroid. 2016;26:1–133.CrossRef
5.
go back to reference ICRP Publication 53, Radiation dose to patients from radiopharmaceuticals. Ann ICRP 1988;18(1–4). ICRP Publication 53, Radiation dose to patients from radiopharmaceuticals. Ann ICRP 1988;18(1–4).
6.
go back to reference ICRP Publication 60, Recommendations of the International Commission on Radiological Protection. Ann ICRP 1991;21(1–3). ICRP Publication 60, Recommendations of the International Commission on Radiological Protection. Ann ICRP 1991;21(1–3).
7.
go back to reference ICRP Publication 73, Radiological protection and safety in medicine. Ann ICRP 1996;26(2). ICRP Publication 73, Radiological protection and safety in medicine. Ann ICRP 1996;26(2).
8.
go back to reference ICRP Publication 94, Release of patients after therapy with unsealed radionuclides. Ann ICRP 2004;34(2). ICRP Publication 94, Release of patients after therapy with unsealed radionuclides. Ann ICRP 2004;34(2).
9.
go back to reference International basic safety standards for protection against ionizing radiation and for the safety of radiation sources, IAEA Safety Series, No. 115, 1996. International basic safety standards for protection against ionizing radiation and for the safety of radiation sources, IAEA Safety Series, No. 115, 1996.
10.
go back to reference Watabe T, Kaneda-Nakashima K, Liu Y, Shirakami Y, Ooe K, Toyoshima A, et al. Enhancement of 211At uptake via the sodium iodide symporter by the addition of ascorbic acid in targeted alpha therapy of thyroid cancer. J Nucl Med. 2019;60:1301–7.CrossRef Watabe T, Kaneda-Nakashima K, Liu Y, Shirakami Y, Ooe K, Toyoshima A, et al. Enhancement of 211At uptake via the sodium iodide symporter by the addition of ascorbic acid in targeted alpha therapy of thyroid cancer. J Nucl Med. 2019;60:1301–7.CrossRef
11.
go back to reference Liu Y, Watabe T, Kaneda-Nakashima K, Ooe K, Shirakami Y, Toyoshima A, et al. Preclinical evaluation of radiation-induced toxicity in targeted alpha therapy using [211At] NaAt in mice: a revisit. Translational oncology. 2020;13:100757.CrossRef Liu Y, Watabe T, Kaneda-Nakashima K, Ooe K, Shirakami Y, Toyoshima A, et al. Preclinical evaluation of radiation-induced toxicity in targeted alpha therapy using [211At] NaAt in mice: a revisit. Translational oncology. 2020;13:100757.CrossRef
12.
go back to reference ICRP Publication 103. The recommendations of the International Commission on Radiological Protection. Ann ICRP. 2007;2007(37):2–4. ICRP Publication 103. The recommendations of the International Commission on Radiological Protection. Ann ICRP. 2007;2007(37):2–4.
14.
go back to reference Koshida Y, Koga S, Orito T, Hiraki T, Takeuchi A, Nishizawa K, et al. Regarding the criteria for returning home and returning to general hospital room for 131I-treated patients based on external doses. Jpn J Nucl Med 1989:591–9. Koshida Y, Koga S, Orito T, Hiraki T, Takeuchi A, Nishizawa K, et al. Regarding the criteria for returning home and returning to general hospital room for 131I-treated patients based on external doses. Jpn J Nucl Med 1989:591–9.
15.
go back to reference Sixth Study Group on the Ideal System for Providing Cancer Treatment — Document 5: Current Status of Nuclear Medicine Treatment (RI Internal Therapy, RI Treatment, Targeted Isotope Treatment) Sixth Study Group on the Ideal System for Providing Cancer Treatment — Document 5: Current Status of Nuclear Medicine Treatment (RI Internal Therapy, RI Treatment, Targeted Isotope Treatment)
17.
go back to reference K. Nishizawa, Ohara K, Ohshima M, Maekoshi H, Orito T, Watanabe T. Monitoring of I excretions and used materials of patients treated with 131I. Health Phys 1980;38:467. K. Nishizawa, Ohara K, Ohshima M, Maekoshi H, Orito T, Watanabe T. Monitoring of I excretions and used materials of patients treated with 131I. Health Phys 1980;38:467.
18.
go back to reference Manual on handling the diapers of patients who have been administered a radiopharmaceutical (Guidelines for medical personnel working in nuclear medicine) (March 2001, 1st ed., March 2004, 2nd ed.). Japanese Society of Nuclear Medicine, Japan Radiological Society, Japanese Society of Radiological Technology, Japanese Society of Nuclear Medicine Technology, and Japan Association on Radiological Protection in Medicine. http://www.jsnm.org/archives/734/. Manual on handling the diapers of patients who have been administered a radiopharmaceutical (Guidelines for medical personnel working in nuclear medicine) (March 2001, 1st ed., March 2004, 2nd ed.). Japanese Society of Nuclear Medicine, Japan Radiological Society, Japanese Society of Radiological Technology, Japanese Society of Nuclear Medicine Technology, and Japan Association on Radiological Protection in Medicine. http://​www.​jsnm.​org/​archives/​734/​.
19.
go back to reference Act Regulating Radioactive Isotopes (Law No. 167, June 10, 1957) Act Regulating Radioactive Isotopes (Law No. 167, June 10, 1957)
20.
go back to reference Medical Care Act (Law No. 205, July 30, 1948) Medical Care Act (Law No. 205, July 30, 1948)
21.
go back to reference Medical Care Act Implementing regulations (Ministry of Health, Labour and Welfare Ordinance No. 50, November 5, 1948) Medical Care Act Implementing regulations (Ministry of Health, Labour and Welfare Ordinance No. 50, November 5, 1948)
22.
go back to reference Ordinance on Prevention of Ionizing Radiation Hazards (Ministry of Health, Labour and Welfare Ordinance No. 41, September 30, 1972) Ordinance on Prevention of Ionizing Radiation Hazards (Ministry of Health, Labour and Welfare Ordinance No. 41, September 30, 1972)
23.
go back to reference Rules of the National Personnel Authority 10–5 (Prevention of radiation hazards for employees) (Rules of the National Personnel Authority 10–5, September 25, 1963) Rules of the National Personnel Authority 10–5 (Prevention of radiation hazards for employees) (Rules of the National Personnel Authority 10–5, September 25, 1963)
25.
go back to reference Revised Medical Radiation Management Practice Manual, Japan Radioisotope Association, 2004. Revised Medical Radiation Management Practice Manual, Japan Radioisotope Association, 2004.
Metadata
Title
Manual on the proper use of sodium astatide ([211At]NaAt) injections in clinical trials for targeted alpha therapy (1st edition)
Authors
Tadashi Watabe
Makoto Hosono
Seigo Kinuya
Takahiro Yamada
Sachiko Yanagida
Masao Namba
Yoshihide Nakamura
Publication date
01-07-2021
Publisher
Springer Singapore
Published in
Annals of Nuclear Medicine / Issue 7/2021
Print ISSN: 0914-7187
Electronic ISSN: 1864-6433
DOI
https://doi.org/10.1007/s12149-021-01619-2

Other articles of this Issue 7/2021

Annals of Nuclear Medicine 7/2021 Go to the issue