RESUMO
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.
Assuntos
Braquiterapia , Neuroblastoma , Humanos , 3-Iodobenzilguanidina , Recursos em SaúdeRESUMO
We present the guideline for use of yttrium-90-labeled anti-P-cadherin antibody injection for radionuclide 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. Treatment using yttrium-90-labeled anti-P-cadherin antibody injection in Japan should be carried out according to this guideline. Although this guideline is applied in Japan, the issues for radiation protection shown here are considered internationally useful as well. Only the original Japanese version is the formal document.
Assuntos
Anticorpos/administração & dosagem , Anticorpos/uso terapêutico , Caderinas/imunologia , Ensaios Clínicos como Assunto , Guias de Prática Clínica como Assunto , Radioisótopos de Ítrio/uso terapêutico , Anticorpos/efeitos adversos , Anticorpos/imunologia , Humanos , Injeções , Marcação por Isótopo , Alta do Paciente , Proteção Radiológica , Segurança , Radioisótopos de Ítrio/efeitos adversosRESUMO
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.