To prevent potential radiation detection issues at international airports following nuclear medicine procedures, our hospital conducts screenings regarding international travel plans both at the time of booking and on the day of the examination. We evaluated the results and clinical utility of these screenings conducted for 6,132 cases over a seven-year period from April 2019 to March 2026. Overall, 1.29% (79 cases) of patients reported planned international travel; however, excluding the COVID-19 pandemic period (April 2020 to March 2022), the rate was 2.24% (77 out of 3,437 cases). Regarding the timing of disclosure, 62.03% (49/79 cases) identified their travel plans during the booking process, while 37.98% (30/79 cases) did not disclose them until the day of the examination. For cases identified at booking, we adjusted the examination schedules for 11 patients and changed the radiopharmaceutical for one patient. For those identified on the day of the procedure, emergency certificates were issued for three patients to proceed with the examination. No examinations were canceled, and there were no reports of post-procedural airport complications. We concluded that screening at the time of booking is essential to enable flexible interventions, such as rescheduling and modifying protocols, to ensure patient safety and convenience.
This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2024 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. Replies were obtained from 989 institutions out of 1,176 to which the questionnaire had been sent. A total of 925,315 radiopharmaceutical administrations were reported. Nine cases of adverse reactions were reported. The incidence of adverse reactions per 100,000 cases was 1.0. No case of defective products was reported.
Internal radiation therapy using Lutetium-177 (177Lu)-PSMA-617 will be approved for PSMA-positive castration-resistant prostate cancer in actual clinical practice soon. At present, NHI medical technical fee for the use of Lutetium-177 (177Lu)-PSMA-617 injection has not been set. The Japanese Society of Nuclear Medicine conducted a health resource use survey in internal radiation therapy using a questionnaire sent to medical institutions which conducted clinical trials. As a result of the investigation, the cost required for treatment management per patient is 1,752,860 JPY, based on the Draft Proposal for Medical Examination Value (Ver.7.4) of the Japanese Health Insurance Federation for Surgery. Lutetium-177 (177Lu)-PSMA-617 is required to be administered every 6 weeks up to 6 times, and the treatment management fee per administration was estimated to be 292,143 JPY and the appropriate NHI medical technical fee is 29,214 points per patient per treatment, which can be claimed 6 times. In addition, Ga-generator and [68Ga] Ga-PSMA-11 elution/preparation work are required for PSMA-PET diagnosis, which is necessary for judging the appropriateness of administration of Lutetium-177 (177Lu)-PSMA-617. It was considered necessary to set an additional cost of 123,083 JPY per patient as the management expenses of Ga-generator, and 12,308 points per 1 administration was considered appropriate as the NHI medical technical fee.
PURPOSE:Radionuclide therapy often involve long waiting periods due to limited numbers of radioisotope therapy rooms and special measures rooms, and strict regulations. The purpose of this study was to estimate the waiting period for radionuclide therapy, considering the increased utilization of nuclear medicine and greater demand due to new drugs. The study also examined possible factors that may limit the treatment provision system and investigate appropriate treatment environments that could shorten the waiting period. METHOD:We developed a discrete event simulation, using three prefectures as a model, to predict the number of patients with a long waiting period and determine the effectiveness of environmental measures designed to shorten the waiting period. The model took considered the demand for radionuclide therapy and medical resources, such as the number of treatment beds, as input values. RESULTS:The simulation predicted that, within 4 years after the introduction of [177Lu]Lu-PSMA-617, the number of patients waiting >180 days for treatment would increase significantly in all three prefectures. The limited number of beds was the leading cause of the long waiting period. However, just increasing the number of beds was ineffective for reducing the waiting period in some facilities due to regulatory factors, and measures to improve the drainage capacity were also necessary. CONCLUSION:The number of patients with a long waiting period is expected to increase significantly due to the rapid increase in demand for radionuclide therapy. A combination of measures, including increasing the number of beds, improving drainage capacity, and better utilization of available medical resources through interfacility cooperation, are factors that need urgent attention to reduce the waiting time for radionuclide therapy.
The Japanese government has shown increasing expectations for the medical application of radioactive isotopes (RIs), as reflected in the 2024 Basic Policy on Economic and Fiscal Management and Reform. Additionally, the Fukushima Instutute for Research, Education and Innovation (F-REI) has launched RI-based diagnostic and therapeutic drug development projects, and the Ministry of Health, Labour and Welfare has proposed a draft guideline for clinical and non-clinical studies of radiopharmaceuticals for therapeutic use. Meanwhile, in Europe, three large-scale theranostics projects began in October 2024. These projects represent the first public-private research initiatives in RI drug discovery, with significant financial support of 60 million euros from the Horizon Europe project of the European Commission and the related industries. In terms of drug development, the Innovative Health Initiative (IHI) plays a key role in funding medical research projects as part of Horizon Europe. It designated the Thera4Care, Accelerate.EU, and ILLUMINATE projects, focusing on theranostics. Thera4Care aims to establish ecosystem for theranostics and expand its use across Europe. Accelerate.EU aims to develop targeted alpha therapy using astatine-211 (211At) for pancreatic, breast, and brain cancers, establishing a sustainable production network. The project plans to conduct phase1 clinical trials by 2028. ILLUMINATE focuses on optimizing lutetium-177 (177Lu)-based therapies for prostate cancer while improving isotope production and supply chains. Japan has RI research initiatives sponsored by F-REI, but lacks strong industry participation and financial contribution mechanisms seen in Europe. It is desirable for researchers to inform companies and related organizations about commissioned projects, and for researchers themselves to improve the environment for joint research. The advancement of theranostics using RIs in Japan requires industry engagement, knowledge dissemination, and workforce training to facilitate clinical applications and foster international collaboration.
This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2023 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. Replies were obtained from 971 institutions out of 1,181 to which the questionnaire had been sent. A total of 884,272 radiopharmaceutical administrations were reported. Fifteen cases of adverse reactions were reported. The incidence of adverse reactions per 100,000 cases was 1.7. No case of defective products was reported.
OBJECTIVE:[64Cu]Cu-ATSM is a radiotherapeutics under clinical trials. It is necessary to take appropriate measures to limit its exposure and ensures its airborne concentrations do not exceed legally permitted levels. Therefore, the purpose of this study was to measure the airborne radioactivity concentration in the inpatient room after administering [64Cu]Cu-ATSM to patients. METHODS:Three patients with malignant glioma were intravenously administered [64Cu]Cu-ATSM (100 MBq/kg ± 10%) in an inpatient room, and the airborne radioactivity concentrations were measured at two locations in the room (in the center of the room and near the entrance of the room) using a filter collection method. RESULTS:After administration of [64Cu]Cu-ATSM, the airborne radioactivity concentrations measured were around or below the limit of detection (8.24×10-7 Bq/cm3 or lower) in all three patients, and all concentrations were consistently below 1/10,000 of the legal airborne concentration limit of 64Cu (1×10-1 Bq/cm3). CONCLUSION:The results of this study confirmed that the airborne concentration of [64Cu]Cu-ATSM after administration to patients was below the legally permitted level.
This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2022 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. Replies were obtained from 1,004 institutions out of 1,181 to which the questionnaire had been sent. A total of 911,977 radiopharmaceutical administrations were reported. Seventeen cases of adverse reactions were reported. The incidence of adverse reactions per 100,000 cases was 1.9 . No case of defective products was reported.
Internal radiation therapy using Iodine-131 metaiodobenzylguanidine (131I-MIBG) for neuroblastoma has been discussed whether a special application scheme for off-labeled drugs called "Kouchi-Shinsei" could be applied to neuroblastoma or not by the Evaluation Committee on Unapproved or Off-labeled Drug with High Medical Needs (the Committee); if the Committee determines that Kouchi-Shinsei is applicable, neuroblastoma indication is expected to be regulatory approved within a year. Since a NHI medical technical fee is not yet set for neuroblastoma, the Japanese Society of Nuclear Medicine surveyed health resource use via a questionnaire survey of medical institution that has conducted a Japanese Advanced Medical Care B clinical study in neuroblastoma. Results showed that the necessary total cost per patient is 1,847,451 JPY when calculated based on the Draft Proposal for Medical Examination Value (Ver. 7.3) of the Japanese Health Insurance Federation for Surgery. Because follow-up is necessary for 3 months after administration, it was considered that an appropriate fee per patient is 1,847,451 JPY and an appropriate NHI medical technical fee per patient is 46,186 points which can be claimed up to once a month for 4 times including the initial month of the treatment.
This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2007 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. The reply was obtained from 994 institutions among 1,259 to which the questionnaire had been sent. Eleven cases of adverse reactions were reported. A total of 1,192,072 radiopharmaceutical administrations was reported. The incidence of adverse reactions per 100,000 cases was 0.9. Three cases of defect products were reported, and the incidence of defect products per 100,000 cases was 0.3.
OBJECTIVE:[177Lu]Lu-PSMA-617 is a radioisotope used in nuclear medicine. It is necessary to take appropriate measures to limit its exposure and ensures its airborne concentrations do not exceed legally permitted levels. Therefore, the purpose of this study was to measure the airborne radioactivity concentration in the inpatient room after administering [177Lu]Lu-PSMA-617 to humans.METHODS:Three males with advanced prostate-specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer were intravenously administered [177Lu]Lu-PSMA-617 (7.4 GBq ± 10%) in an inpatient room, and the airborne radioactivity concentrations were measured at two locations in the room (in the center of the room and at the bedside) using a filter collection method.RESULTS:After administration of [177Lu]Lu-PSMA-617, the airborne radioactivity concentrations measured were below the limit of detection (1.1 × 10-6 Bq/cm3 or 9.5 × 10-7 Bq/cm3) in all three humans, and all concentrations were consistently below the standard value of 1/10,000 of 2 × 10-2 Bq/cm3, the legal airborne concentration limit of 177Lu.CONCLUSION:The results of this study confirmed that the airborne concentration of [177Lu]Lu-PSMA-617 after administration to humans was below the legally permitted level.
This survey was performed to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2020 in Japan. The results are based on responses to questionnaires sent to nuclear medicine centers. Replies were obtained from 1,006 centers out of 1,212 to which the questionnaire was sent. A total of 940,758 administrations of radiopharmaceuticals were reported. There were 17 cases with adverse reactions, giving an incidence of adverse reactions of 1.8 per 100,000 cases. Two cases of defective products were reported, giving an incidence of defective products of 0.2 per 100,000 cases.
OBJECTIVE:To perform an exploratory analysis on the safety and effectiveness of radium-223 (Ra-223) by patient baseline age, using the results of a post-marketing surveillance study of Ra-223 in castration-resistant prostate cancer patients with bone metastasis in Japan.METHOD:The safety analysis population of 296 patients was stratified into two groups based on age (<75 and ≥ 75 years-old [yo]), and their characteristics, drugrelated treatment-emergent adverse events (TEAEs), and clinical laboratory values were evaluated. Additionally, these endpoints were evaluated in patients aged ≥ 80 yo.RESULTS:There were 148 patients in each of the <75-yo and ≥ 75-yo age groups, and 69 patients in the ≥ 80-yo age group. The characteristics of patients in the <75-yo group were suggestive of more aggressive disease at diagnosis of prostate cancer and a greater proportion of patients had prior chemotherapy compared with patients in the ≥ 75-yo age group. The incidences of overall drugrelated TEAEs and drug-related hematological TEAEs were slightly higher in the <75-yo age group; however, there was little difference in the incidences of drug-related TEAEs leading to drug discontinuation (1.4-4.1%) between patient groups. Changes in total alkaline phosphatase and prostate-specific antigen values were similar in all groups.CONCLUSIONS:Ra-223 therapy seemed tolerable regardless of age in real-world practice in Japan. Especially, there were no new safety concerns of Ra-223 in elderly patients.
131I-3-iodobenzylguanidine or 131I-iobenguane (3-(131I) iodobenzylguanidine or 131I-iobenguane [131I-MIBG]) is a radioactive agent that is specifically accumulated in tumor cells such as pheochromocytoma and neuroblastoma. Due to its cytotoxic beta ray emitted from 131I, it has been developed as an agent for radioisotope therapy and some researchers have reported its effectiveness. In this study, based on the patients' data from previous clinical trials of 131I-MIBG therapy, we evaluated the radiation safety for public exposure caused by radiation emitted from patients who received 131I-MIBG. In results, it was considered that public exposure and medical exposure of visitors and caregivers to the patients were less than their dose limit and dose constraint by complying the current criteria of the release of patients after therapy with 131I.
Quality of the 68Ga solution eluted from a 68Ge/68Ga generator (Galli Eo®) was evaluated. Elution was performed 488 times from 21 to 484 days (ca. 15 months) after the calibration date. The eluted 68Ga activity was 329 MBq to 1,148 MBq, which decreased with the decay of 68Ge, but no significant change was observed in the elution yields (62.8±2.2%). The half-life of the eluted radioactivity was 67.8±0.1 min, the radionuclide purity of 68Ga was ≥99.9%, the 68Ge breakthrough was 0.000024 ±0.000004%, and the radiochemical purity of 68Ga3+ was 99.7±0.2%. Fe and Zn were detected as metal impurities in the eluent, but both were ≤10 μg/GBq. The endotoxin concentration of the eluate was ≤5 EU/mL, and the eluent passed the sterility test. These results show that the generator can stably provide 68Ga solution over a 15-month period.
Internal radiation therapy using lutetium-177(177Lu)-DOTA-TATE injection will be applied in actual clinical practice soon. However, the NHI medical technical fee for the use of 177Lu-DOTA-TATE injection has not yet been set. The Japanese Society of Nuclear Medicine surveyed health resource use in internal radiation therapy using 177Lu via questionnaires sent to medical institutions that have used 177Lu-DOTA-TATE injection. Results showed that the necessary cost per patient is 1,912,404 JPY, based on the Draft Proposal for Medical Examination Value (Ver. 7.2) of the Japanese Health Insurance Federation for Surgery. 177Lu-DOTA-TATE injection is supposed to be administered 4 times to each patient at 8-week intervals, and the fee per treatment was calculated to be 478,101 JPY. The appropriate NHI medical technical fee is thus considered to be 47,810 points per patient per treatment, which can be claimed 4 times per patient. In addition, it costs 649,030 JPY per patient to take special measures to make the hospital room similar to the radiation therapy room. The cost other than the basic hospitalization fee per day was calculated to be 81,129 JPY. The appropriate additional points for NHI basic hospitalization fee is thus considered to be 8,113 points per patient per day.
Internal radiation therapy using 3-iodobenzylguanidine (131I) injection (131I-MIBG injection) will be applied in actual clinical practice soon. However, the NHI medical technical fee for the use of 131I-MIBG injection has not yet been set. The Japanese Society of Nuclear Medicine surveyed health resource use for internal radiation therapy using 131I via questionnaires sent to medical institutions that have used 131I-MIBG injection. Results showed that the necessary cost per patient is 1,912,671 JPY, which was based on the Draft Proposal for Medical Examination Value (Ver. 7.2) of the Japanese Health Insurance Federation for Surgery. 131I-MIBG injection is supposed to be administered once to each patient and the patient is followed up for 4 months after administration. The fee per treatment is calculated to be 478,168 JPY per month. The appropriate NHI medical technical fee is thus considered to be 47,817 points per month per patient per treatment, which can be claimed up to 4 times.
PURPOSE:We developed and validated the accuracy of a method to calculate the arterial input function (AIF) from PET images only, without the need for the arterial blood sampling, in the absolute quantitation of functional parametric values in 15O- gas PET examinations.METHODS:We extended the method reported by Iguchi et al. (2013) to derive the arterial input function, thus absolute quantitative functional parametric images of cerebral perfusion and oxygen metabolism by a reference tissue approach. We compared shapes of the AIF and reproducibility of the absolute functional values. Existing test data that were carried out with the continuous arterial blood sampling were used for this study.RESULTS:The estimated AIF shapes agreed well with those estimated from the continuous arterial blood sampling. The error range of the absolute quantitative values was approximately ±20%, with a fairly well reproducibility in the relative values being less than 3%.CONCLUSION:The AIFs by this method were reproducible. Although the absolute quantitative values varied depending on the assumed functional values in the reference region in individual cases, the relative images showed fairly good agreement with the results from the standard technique that employed the arterial blood sampling. The present technique may provide significant contribution to clinical examination.
This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2019 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. Replies were obtained from 1,003 institutions out of 1,213 to which the questionnaire had been sent. A total of 1,037,568 radiopharmaceutical administrations were reported. Eighteen cases of adverse reactions were reported. The incidence of adverse reactions per 100,000 cases was 1.7. No case of defective products was reported.
To establish a feasible and practical methodology for harmonization of FDG-PET, we have investigated quantitative physical performance of recent clinical PET scanners (23 scanners) using the NEMA image quality phantom. Compared with the previous phantom data (13 scanners) acquired in the early 2000s, the current phantom data showed better contrasts of small spheres even with a smaller number of coincidence counts. This result suggests that clinical PET image quality and small lesion detectability might have been significantly improved in the past 10 years. Based on the data acquired in this working group, we are planning to update the standard phantom test methodology and harmonizing criteria for FDG-PET.
