In vitro diagnostic nuclear medicine is a medical biology technique used to assay certain compounds contained in the biological fluids sampled beforehand from the patient (e.g. hormones, tumoral markers, etc.); it is used frequently because it has the highest detection sensitivity of the techniques using ionising radiation. This technique uses assaying methods based on immunological reactions (reactions between antigens and antibodies marked with iodine-125), hence the name Radio Immunology Assay or radioimmunoassay – RIA). However, the number of in vitro diagnostic laboratories is decreasing due to the use of techniques offering greater detection sensitivity, such as immunoenzymology or chemiluminescence. Nuclear medicine for therapeutic purposes, or ITR, uses the administration of the RPD to deliver a high dose of ionising radiation to a target organ for curative or palliative purposes. Two areas of therapeutic application of nuclear medicine can be identified: oncology and non-oncological diseases. Human Subject Research (HSR) in nuclear medicine has been particularly dynamic in recent years, primarily in the field of oncology therapy with the emergence of new vectors and radionuclides. ITR treatments can be administered either by mouth (e.g. capsule of iodine-131) or by systemic route (intravenous injection or a catheter). Some treatments – depending on the administered activity or the nature of the radionuclide used – require patients to be hospitalised for several days in specially fitted-out rooms in the nuclear medicine department to ensure the radiation protection of the personnel, of people visiting the patients and of the environment. The radiological protection of these rooms is adapted to the nature of the radiation emitted by the radionuclides, and the contaminated urine of the patients is collected in tanks. 45 nuclear medicine departments have a combined total of 167 ITR rooms for therapeutic purposes (see Graph 4). Medical dispensaries When a medical dispensary is authorised in a health care centre, the room in the nuclear medicine department in which RPD are prepared, called the “nuclear pharmacy” or “radiopharmacy”, is part of the medical dispensary. In 2019, there were 128 nuclear pharmacies in the nuclear medicine departments in public health care institutions and non-profit private health care institutions, such as the cancer centres. The radiopharmacist is primarily responsible for managing the RPD circuit (procurement, possession, preparation, control, dispensing and traceability) and the quality of preparation. The ANSM published a guide to Good preparation practices on 20 September 2022, which will come into effect on 20 September 2023, replacing the guide dating from 2007. The equipment In addition to the cameras installed in the nuclear medicine departments, radiation-proof enclosures are installed in the departments to permit safe handling of unsealed sources. Automated or semi-automated preparation units are also used for the preparation of fluorine-18 labelled RPD, along with automated injection units. 2.3.2 Technical rules applicable to nuclear medicine facilities The radiation protection constraints specific to nuclear medicine are linked to the use of radionuclides in unsealed sources. The departments are designed and organised for the reception, storage and handling of these unsealed radioactive sources with a view to their administration to patients or in the laboratory (in the case of radioimmunology). Provision is also made for the collection, storage and disposal of radioactive wastes and effluents produced in the facility, particularly the radionuclides contained in patients’ urine. Compliance with the technical design, operating and maintenance rules of nuclear medicine departments Nuclear medicine departments must satisfy the rules prescribed by ASN resolution 2014-DC-0463 of 23 October 2014 relative to the minimum technical rules of design, operation and maintenance to be satisfied by in vivo nuclear medicine facilities. This resolution details in particular the rules for the ventilation of nuclear medicine department premises and the rooms accommodating patients receiving, for example, treatment for thyroid cancer with iodine-131. Guide No. 32 detailing certain aspects of this resolution was published by ASN in May 2017 and was updated in February 2020. In addition, facilities equipped with a CT scanner coupled with a gamma-camera or a PET camera must comply with the provisions of ASN resolution 2017-DC-0591 of 13 June 2017 laying down the minimum technical design rules to be satisfied by premises in which electrical devices emitting X-rays are used. Management of waste and effluents from nuclear medicine departments The management of waste and effluents potentially contaminated by radionuclides must be described in a management plan which includes, more specifically, the conditions of monitoring of discharged effluents in accordance with Article R. 1333‑16 of the Public Health Code and ASN resolution 2008-DC-0095 of 29 January 2008. Premises must be dedicated to these activities, as must specific equipment for monitoring the conditions of effluent discharges (tank filling levels, leakage alarm systems, etc.). The compliance of the facilities for collecting the effluents and wastes produced by nuclear medicine departments must be verified regularly. Revision of this resolution began at the end TABLE Main radionuclides used in diverse in vivo nuclear medicine examinations TYPE OF EXAMINATION RADIONUCLIDES USED Thyroid metabolism Iodine-123, technetium-99m Myocardial perfusion Rubidium-82, technetium-99m, thallium-201 Lung perfusion Technetium-99m Lung ventilation Krypton-81m, technetium-99m Osteoarticular process Fluorine-18, technetium-99m Renal exploration Technetium-99m Oncology – search for metastases Fluorine-18, gallium-68, technetium-99m Neurology Fluorine-18, technetium-99m 3 222 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 07 • Medical uses of ionising radiation 07
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