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.
Highlights
Keywords [211At] sodium astatide · Targeted alpha therapy · Radiation protection · Thyroid cancer. Purpose of this safety management manual. This safety management manual is a compilation of implementation guidelines for clinical trials with the purpose of ensuring the safe handling of [211At] sodium astatide ([211At]NaAt) in compliance with the principles of the Safety Guidelines for the “release of patients administered
One of the features of nuclear medicine is molecular targeted therapy, wherein the administered radiopharmaceutical is selectively accumulated in the lesion, and localized irradiation is performed
This manual incorporates the points established in the Medical Care Act, and recommendations on radiological protection established by international organizations [4,5,6,7,8]; ideally, healthcare facilities that implement this treatment must follow the requirements covered in this manual to ensure radiation safety
Summary
This safety management manual is a compilation of implementation guidelines for clinical trials with the purpose of ensuring the safe handling of [211At] sodium astatide ([211At]NaAt) in compliance with the principles of the Safety Guidelines for the “release of patients administered. Patients, family members, and other concerned parties must fully understand the aspects of nuclear medicine treatment This manual incorporates the points established in the Medical Care Act, and recommendations on radiological protection established by international organizations [4,5,6,7,8]; ideally, healthcare facilities that implement this treatment must follow the requirements covered in this manual to ensure radiation safety. (2) This treatment should be carried out at healthcare facilities with full-time doctors and radiology technologists with sufficient knowledge and experience in handling radiopharmaceuticals. It should be performed in hospitals with specialized knowledge and experience in the treatment of thyroid cancer. Considering the unique characteristics of this drug, hospitals that perform this treatment must meet the requirements stipulated here, namely to perform this treatment with medical teams consisting of physicians, radiology technologists involved in radiological safety management, nurses involved in patient care and assistance, and other health professionals
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