Administration Facility Unit

Abstract

To provide an easily installable and removable radiation controlled area.SOLUTION: One embodiment of the present invention is an administration facility unit 101 of a substance containing radioactive nuclides. The substance contains (a) only an α ray emitting radioactive nuclide, or (b) only the α ray emitting radioactive nuclide and a decay product thereof. The administration facility unit 101 is transportable, and has a radiation controlled area 400 and a sickbed 201 set inside the radiation controlled area.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an administration facility unit for administering radionuclide-containing substances to humans. [Background technology]

[0002] Internal radiation therapy for cancer includes brachytherapy (a radioactive source is placed near the lesion) and non-brachytherapy. The effectiveness of brachytherapy is similar to that of external radiation. Non-brachytherapy (TRT: targeted radionuclide therapy, also called targeted isotope therapy, nuclear medicine therapy, and internal therapy) is a method of concentrating a radioactive source in a specific part of the body according to the specific biodistribution of the medicine containing the radioactive source. Therefore, the medicine is administered to the patient orally or parenterally.

[0003] The above medicines mainly emit beta or gamma rays, except for Xofigo®, which was approved by the FDA in May 2013 as the world's first medicine containing an alpha-emitting radionuclide, and was also approved as a medicine by the Ministry of Health, Labor and Welfare in March 2016. Xofigo® is currently the only medicine in Japan that contains an alpha-emitting radionuclide. [Prior art documents] [Non-patent literature]

[0004] [Non-Patent Document 1] Nuclear Medicine, Vol. 48, No. 2 (2011), pp. 121-137 Summary of the Invention [Problem to be solved by the invention]

[0005] In recent years, medicines containing alpha-particle-emitting radionuclides have been expected to play a central role in TRT due to their high therapeutic effect and low side effects on surrounding tissues (they are also part of the Third Basic Plan for Promoting Cancer Control Measures).

[0006] However, in reality, there is no place to conduct various tests (not for therapeutic administration) on drug candidates containing alpha-emitting radionuclides in order to have them approved as medicines by the Ministry of Health, Labor and Welfare, because the use of the drug candidates is permitted only within radiation-controlled areas.

[0007] There are few hospital beds in radiation controlled areas (approximately 150 beds nationwide). In radiation controlled areas, the permitted amount of radionuclide use per certain period (e.g., one year) is determined mainly according to the size of the facilities installed. Therefore, unless the implementation of existing treatments and examinations is reduced from the previous year, the above-mentioned hospital rooms cannot be used for additional testing of the above-mentioned drug candidates (including administration to humans). Furthermore, there is little prospect of new construction or expansion of facilities as buildings that house such hospital rooms.

[0008] The construction (initial cost) of the above facilities is expected to require a large amount of money (approximately 400 to 500 million yen). In addition to the normal construction costs (required for securing the land and ensuring the robustness of the buildings), the radiation controlled area will require costs for the following equipment. The following equipment is also required for the expansion of the above facilities. Shielding (to keep radiation levels outside radiation controlled areas below legal limits) Intake and exhaust equipment (keep radiation levels within legal limits at the border of radiation control areas) Underground or above-ground storage tanks (to store wastewater containing radioactive materials and shield it from radiation).

[0009] The temporary treatment facility for internally exposed patients disclosed in Non-Patent Document 1 requires a concrete enclosure (corresponding to the above-mentioned shielding) and a waste facility unit (including the above-mentioned storage tank) in addition to the treatment room unit.

[0010] Therefore, an object of the present invention is to provide a radioactive controlled area that is easy to install and remove. [Means for solving the problem]

[0011] In order to solve the above problems, one embodiment of the present invention provides an administration facility unit for a substance containing a radioactive nuclide, the substance containing, as radioactive nuclides, (a) only alpha-ray-emitting radioactive nuclides, or (b) only alpha-ray-emitting radioactive nuclides and decay products of the alpha-ray-emitting radioactive nuclides, the administration facility unit being portable and comprising a radiation-controlled area and a hospital bed located within the radiation-controlled area. Effect of the Invention

[0012] According to one aspect of the present invention, it is possible to provide a radioactive control area that is easy to install and remove. [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 shows an overview of an administration facility unit (including a vehicle carrying the unit) according to one embodiment. [Diagram 2] FIG. 2 is a detailed diagram showing the arrangement of equipment provided in the administration facility unit of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] [Administration Facility Unit] The administration facility unit according to one embodiment of the present invention is an administration facility unit for a substance containing a radionuclide, the substance containing, as radionuclides, (a) only α-emitting radionuclides, or (b) only α-emitting radionuclides and decay products of the α-emitting radionuclides, the administration facility unit being portable and comprising a radiation-controlled area and a hospital bed located within the radiation-controlled area.

[0015] (Terminology explanation) An "administration facility unit" refers to a unitary structure that includes the necessary equipment for administering radioactive materials to humans. All or part of the administration facility unit is a radiation controlled area (described in detail below). Thus, for example, clinical trials, investigations, and treatments using materials containing alpha-emitting radionuclides can be carried out in the administration facility unit.

[0016] An alpha-emitting radionuclide (also called an alpha-emitter or alpha-radionuclide) is an atom that contains a nucleus that decays by emitting alpha particles. Thus, a "material containing a radionuclide" refers to both the atom itself and a compound in which the atom is bound to one or more other atoms.

[0017] The state "(a) containing only α-ray emitting radionuclides, or (b) containing only α-ray emitting radionuclides and decay products of the α-ray emitting radionuclides" is determined by a detection method using a spectrometer (e.g., a germanium semiconductor detector and a silicon semiconductor detector) capable of detecting radiation emitted from the above-mentioned material. The germanium semiconductor detector detects gamma rays. Many of the decay products of the α-ray emitting radionuclides that undergo α-decay emit gamma rays. Gamma rays show an energy distribution having a characteristic peak according to the energy of the decay product. By confirming that the energy distribution contains the characteristic peak and that there are no other peaks, the above state (the presence of a specific α-ray emitting radionuclides or decay products) can be confirmed. The nuclide and dose can also be directly identified by a silicon semiconductor detector.

[0018] The α-ray emitting radioactive nuclide is any known α-decay nuclide. Preferred α-ray emitting radioactive nuclide includes nuclides that fall under one or more of (1) to (3). (1) A nuclide having a half-life that is easy to handle as a therapeutic drug, (2) A nuclide for which a manufacturing method has been established, or (3) A nuclide for which effectiveness on cells or living organisms has been reported. The half-life is, for example, 40 days or less, preferably 30 days or less, more preferably 20 days or less, and even more preferably 14 days or less. As for (2), nuclides manufactured for animal experiments (e.g., Tb-149, Pb-212, Bi-212, Bi-213, At-211, Ra-223, Ra-224, and Ac-225) are preferred, nuclides manufactured for human clinical trials (e.g., Pb-212, Bi-213, At-211, Ac-225, and Ra-223) are more preferred, and commercially available nuclides (e.g., Ra-223) are most preferred. Alternatively, (3) is selected from Tb-149, Pb-212, Bi-212, Bi-213, At-211, Ra-223, Ra-224, and Ac-225, which have been reported to be effective on cells or living organisms.

[0019] A "radiation controlled area" refers to an area stipulated in relevant laws and regulations governing the use of radiation for the purpose of safely handling and managing radioactive materials or radiation generating devices (radiation from them). For example, according to the relevant Japanese law, the "Act on the Regulation of Radioisotopes, etc.", the dose limit at the boundary of the controlled area is 1.3 mSv / 3 months, and the dose limit at the boundary of the business establishment is 250 μSv / 3 months. A radiation controlled area that meets the dose limit at the boundary of the business establishment can be placed without going through complicated procedures in land and facilities that do not fall under the business establishments stipulated in the above law. For example, according to the provisions of the above law, the type and thickness of the shielding material depends on the nuclide and the amount used in the radiation controlled area. Therefore, the shielding material in the radiation controlled area that constitutes at least a part of the administration facility unit is required to shield against one or more of alpha rays, beta rays, and gamma rays, or all of them, depending on the nuclide. For example, in clinical use, I-131 requires the source to be surrounded by 7.5 cm of lead, and 7.5 cm of lead between the source and the operator, whereas Ac-225 requires a lead thickness of at least 0.3 mm.

[0020] "Transportable" means that the administration facility unit can be transported by a means of transportation (such as a vehicle, railroad, ship, or aircraft) or lifted by a hoist (such as a crane). As described above, the radiation-controlled area of ​​the administration facility unit is surrounded by thin, light shielding and therefore falls under the "radiation-controlled area" defined by the Law Concerning the Regulation of Radioisotopes, etc.

[0021] (The usefulness of a dosing facility unit primarily dedicated to the use of alpha-emitting radionuclides) As can be understood from the explanation of terms, the administration facility unit (a structure that is not a building by itself) can realize a portable radiation-controlled area (with hospital beds installed inside) where alpha-emitting radionuclides (materials that contain them) can be administered. The reasons why the realization of the administration facility unit will be required in the future are explained below.

[0022] Reason 1 It was around 2006 that medical professionals began to recognize the seriousness of the effects of alpha radiation in the human body (and that it could be effective if the radiation could be controlled). In 2013, a substance containing an alpha-emitting radionuclide was recognized for the first time in the world (by the FDA) as safe and effective as a cancer treatment. In 2016, the Ministry of Health, Labor and Welfare approved Xofigo (registered trademark), which had already been approved by the FDA, as a treatment for some cancers. The enhancement of radiation therapy in the Third Basic Plan for Promoting Cancer Control Measures clearly includes the practical application of the above-mentioned substances other than Xofigo (registered trademark).

[0023] Therefore, the use of the newly developed substances (such as conducting tests to obtain approval as therapeutic drugs and administering the substances as therapeutic drugs) is something that is likely to occur in the future. The inventors of the present application anticipate that this expansion will create a new demand for radiation-controlled areas (with hospital beds installed inside) that can essentially handle only alpha-emitting radionuclides. In order to meet this demand, the inventors of the present application have conducted intensive research and completed the present invention.

[0024] Reason 2 A portable radiation-controlled area with hospital beds installed inside (equipped with space where humans can live inside) has not been realized so far. Non-Patent Document 1 merely discloses a "portable hospital room" that can be called a radiation-controlled area only when a non-portable shield (using concrete and / or lead) is constructed on the outside. The technology disclosed in Non-Patent Document 1 cannot identify the radiation emitted within the "portable hospital room," and the above shield is necessary to block all radiation (e.g., alpha rays, beta rays, and gamma rays).

[0025] X-ray inspection vehicles are transportable within a radiation controlled area. The high permeability of X-rays makes the above shielding essential. The area of ​​the inspection (irradiation) room in the X-ray inspection vehicle is 1m 2The weight of the shielding surrounding this area is within the range of transportability. On the other hand, in order to realize a radiation controlled area in which a substance containing any radioactive nuclide is administered to a human subject or patient and the containing space (a hospital room including hospital beds) is shielded with concrete and / or lead, the weight of the shielding surrounding the containing space becomes excessive and cannot be transported. Thus, the construction and expansion of facilities (which have hospital beds within a radiation controlled area) that are difficult to install and remove is neither ideal nor realistic, as described in the section "Problem to be solved by the invention."

[0026] By using light and thin shielding in the radiation controlled area, (1) the radiation controlled area in which hospital beds are located can be significantly lightened, (2) the lightweight radiation controlled area makes it possible to transport the administration facility unit, and (3) the transportable administration facility unit reduces the construction costs or expansion costs of the facility as a building, and enables the administration facility unit itself to be easily installed and removed (the administration facility unit can be installed at any time and place).

[0027] Reducing radiation reaching the boundary of the radiation control area (4) makes it possible to use smaller-capacity ventilation equipment.

[0028] The use of light, thin shielding for the storage tank (5) significantly reduces the weight of the storage tank, (6) enables the storage tank to be installed within a radiation controlled area (i.e., makes it transportable), and (7) eliminates the cost of burying the storage tank or the need to secure a site to install the storage tank.

[0029] A dosing facility unit specialized for the use of alpha-emitting radionuclides can employ light and thin shielding in radiation controlled areas, and can meet the above-mentioned demands.

[0030] (Use of administration facility units as branches of medical facilities) One embodiment of the present invention will be described by taking as an example a case where the administration facility unit is installed in an unused area (parking lot) in an existing facility (hospital). The branch of the medical facility may be a treatment room or a clinical trial room. The following description will be given by taking as an example a clinical trial room.

[0031] The administration facility unit is transported and set up in the parking lot of the hospital. Medical personnel from the hospital (1) travel to the administration facility unit to conduct the clinical trial (e.g., administering the test substance to the subjects) and (2) manage and monitor the subjects remotely using equipment in the administration facility unit. During the trial, the subjects reside in the administration facility unit and receive further medical care and treatment as needed.

[0032] The administration facility unit does not have to be dedicated to one hospital. After the trial period is over or when no trial is scheduled to be conducted, the administration facility unit can be transferred to another hospital or the like and used for purposes other than clinical trials (e.g., as a treatment room). One or more of the administration facility units are portable and therefore can be shared or temporarily rented by multiple hospitals. Thus, the administration facility unit can meet the demand for treatment procedures that differ from region to region over a wide area.

[0033] Preferred requirements for a radiation controlled area in which clinical trials are conducted include the following (a) to (c).

[0034] (a) Preferred requirements for medical space (in accordance with the Medical Care Act) - Space and facilities for hospital beds (hospital rooms, beds, toilets, wash basins, storage shelves, etc.) - Simple bed (equipment where patients can lie down in places other than a hospital bed, such as when administering medication) -On-call function (doorbell) -Lighting equipment -Air conditioning equipment - Facilities and equipment to ensure a high quality of life (TV, refrigerator, shower, WiFi (registered trademark), soundproofing, etc.) -Installation of emergency exits on a different side from the normal entrance and exit.

[0035] (b) Requirements for a radiation controlled area (in accordance with the Law Concerning the Regulation of Radioisotopes, etc.) - Intake and exhaust equipment and filters (to keep the concentration of radioactive materials below a certain level) - Drafts and filters (to avoid scattering of radiopharmaceuticals which are treated as unsealed sources) - Wastewater storage facilities for radioactive wastewater - A shield that separates areas and spaces that may be subject to high radiation from other spaces. -Waste storage facility with sufficient shielding and fire resistance - A radiation source storage facility with sufficient shielding and fire resistance -Radiation detectors and measuring instruments (inspection of contamination at entrance and exit, exhaust and wastewater monitors) - Locking feature to restrict access to the general public, including hospitalized patients.

[0036] (c) Preferred requirements specific to mobile devices -Communication equipment for communicating with parent facilities such as the hospital -Remote patient monitoring equipment (CCTV) -Nursing robots -Power supply equipment (generators, power storage equipment, or equipment that receives power from an external power source) - a clean water storage tank and a waste water storage tank, preferably of the same volume (e.g. about 4000 L) - Towing function required when moving -Means for fixing the unit (vehicle chocks, anchors and outrigger functions) - Shock resistance and robustness (the unit itself does not need to be earthquake-resistant) - Connectivity and expandability allow ancillary equipment and functions such as drainage tanks and generators to be installed in adjacent locations, such as on other mobile bodies, in order to make effective use of space.

[0037] (Specific examples of administration facility units) An example of the administration facility unit that satisfies the above-mentioned requirements (a) to (c), and a combination with a transport means (a vehicle carrying the administration facility unit) are shown in Figures 1 and 2. In the following description, the configurations shown with the component numbers are specific examples that minimally satisfy the requirements (a) to (c).

[0038] 1 and 2, the administration facility unit 101 is loaded onto a towing vehicle 102. The administration facility unit 101 is equipped with a rest room 200 (radioactive controlled area), an administration room / work room (radioactive controlled area) 400, a toilet room 300 (equipped with a flush toilet 209 and a shower 210), a storage room 600, a management room 500, and a duct space. The vehicle 102 is equipped with an intake and exhaust means (blower, exhaust fan, or compressor) 418 and a radioactive wastewater storage tank 408 in the towing section.

[0039] One of the partitions between the rest room 200 and the administration room / work room 400 is a sliding door, and there is an unlocked door between the administration room / work room 400 and the toilet room 300. Therefore, people inside the administration facility unit 101 can freely move between the rest room 200, the administration room / work room 400, and the toilet room 300 and use the facilities in the three rooms. On the other hand, the door at the entrance / exit of the administration facility unit 101, the door between the administration room / work room 400 and the storage room 600, and the door between the storage room 600 and the management room 500 are locked with electronic locks 501 (in FIG. 1, five locks are shown diagrammatically by a picture of a padlock). Therefore, people who cannot unlock the electronic locks 501 (such as people who do not have an electronic entry pass) cannot enter the management room 500 and the storage room 600.

[0040] The rest room (radioactive controlled area) 200 is equipped with a bed (sickbed) 201, lighting 213, an outlet (100V, 15A) 214, on-call equipment 301, security camera 302, air intake and exhaust vent 403, a controlled area dosimeter 417, a desk, a shelf, wireless LAN, storage, a refrigerator, a microwave oven, a television receiver, and an air conditioning sensor (temperature and humidity). In other words, the rest room 200 is a medical space that complies with the Medical Care Act, and is equipped with facilities that allow subjects to stay quiet and comfortable, and allow medical personnel to monitor the progress of clinical trials. The above-mentioned components in the rest room 200 that are not numbered are mainly components that further improve the habitability of the subjects in the rest room 200. The lighting 213 is shown as six light bulbs in FIG. 1, but is an optional lighting fixture. The air intake and exhaust vent 403 in the rest room 200 sends clean air in a direction that does not directly hit the subject in the bed 201. The surveillance camera 302 captures images of the inside of the rest room 200 (mainly the bed 201 ) and reports the state of the subject to medical personnel via the management room 500 .

[0041] The administration room / work room (radioactive controlled area) 400 is equipped with an outlet 214, a contamination inspection room 402, an intake / exhaust vent 403, a draft chamber for handling unsealed radioactive sources 404, a dosimeter in the controlled area 417, a simple bed, and washing facilities. The draft chamber for handling unsealed radioactive sources 404 is a cabinet in which the unsealed radioactive sources removed from the shielding are handled (for example, the source is diluted to the administration concentration, the diluted source is transferred to an administration container, and the test substance is prepared). The intake / exhaust vent 403 of the administration room / work room 400 sends the air in the room to the piping in the duct space (see FIG. 2). The simple bed is a bed on which the subject lies down to receive the administration of the test substance. The subject can receive the administration of the test substance while sitting on a chair, or while lying on the bed 201 in the rest room 200. The washing facilities are used for hand washing and washing by the subject and medical staff.

[0042] The contamination inspection room 402 is equipped with a contamination inspection device (survey meter) 405, a controlled area boundary dosimeter 415, and a door. The contamination inspection room 402 is partitioned by a curtain (represented by a two-dot chain line and multiple V-shapes in FIG. 1). The contamination inspection device 405 is a small device that detects the dose on the body surface of a person exiting the administration facility unit 101. The controlled area boundary dosimeter 415 is an instrument that measures the air dose near the door, and determines the effective dose at the controlled area boundary, which will be described later.

[0043] On the outer wall of the administration room / work room 400 (for example, above the door), there are a surveillance camera 302, a sign 401, and a facility boundary dosimeter 413, and a staircase is placed outside the door. The facility boundary dosimeter 413 is an instrument that measures the air radiation dose outside the unit and determines the effective dose at the facility boundary, which will be described later. People going up and down the staircase and people opening and closing the door are both photographed and recorded by the surveillance camera 302. A sign 401 indicating that the administration facility unit 101 is a radiation controlled area is attached to the door. A sign 401 is also attached to an emergency exit (for example, on the left side outside the control room 500). The staircase does not have to be a part of the administration facility unit 101, and can be a prefabricated staircase loaded on the vehicle 102. In FIG. 1, the solid line indicating the opening and closing of the door indicates a normal entrance and exit, and the two-dot chain line indicating the opening and closing of the door indicates an emergency exit or a door that is normally closed.

[0044] The storage room 600 includes a storage unit 406 and a storage room dosimeter 416. The storage unit 406 stores unsealed radiation sources used in the unsealed radiation source handling draft 404, and waste that may be contaminated with radioactive materials. The walls of the storage unit 406 contain a material (such as lead) that shields radiation. The door of the storage unit 406 is locked, as shown in FIG. 1. The storage room dosimeter 416 is an instrument that measures the air radiation dose in the storage room 600.

[0045] The management room 500 includes an intake / exhaust port 403, a computer 502, and a power receiving equipment 503. The intake / exhaust port 403 supplies clean air into the management room 500. The power receiving equipment 503 is equipment for receiving power supply from outside the administration facility unit 101. The power receiving equipment 503 distributes the power supplied from outside to all the outlets 214 via the EPS.

[0046] As shown in Fig. 2, the rest room 200, the administration room / work room 400, and the control room 500 each have an intake / exhaust port 403 and an anti-phase sound silencing device (a microphone in Fig. 2). The intake / exhaust port 403 is connected to an external exhaust port 412 through piping in the duct space. The dose contained in the exhaust air that passes through a filter (not shown) and is sent to the external exhaust port 412 is measured by a gas monitor (exhaust dosimeter) 414.

[0047] The computer 502 is electrically connected to the electrically driven mechanical devices (the above-mentioned anti-phase silencer, the lighting 213, the on-call equipment 301, the surveillance camera 302, the intake and exhaust port 403, the dosimeters 414-417, the intake and exhaust means 418, and the electronic lock 501). The computer 502 outputs electrical signals to drive the above-mentioned mechanical devices according to a preset program, and records the operation of the above-mentioned mechanical devices represented by the electrical signals (air conditioning, dose rate, entry and exit records, CCTV data, etc.). In other words, the computer 502 controls the operation of the above-mentioned mechanical devices and monitors the operation. The computer 502 transmits the recorded information to a display device or a wireless communication unit.

[0048] The toilet room 300 is equipped with a flush toilet 209 and a shower 210. The flush toilet 209, the shower 210 and the above-mentioned washing equipment receive water from an external water supply pipe (not shown). Wastewater from the flush toilet 209, the shower 210 and the above-mentioned washing equipment is sent to a radioactive wastewater storage tank 408 through a radioactive wastewater outlet 410 located under the floor. A portion of the wastewater in the radioactive wastewater storage tank 408 can be collected from a radioactive wastewater collection port 409 in order to examine the dose of the wastewater. Although an example has been described in which the administration facility unit 101 receives water from an external source, the vehicle 102 may further include a water supply tank in its towing section.

[0049] As described above, the administration facility unit 101 is equipped with the equipment required for a radiation controlled area (400 series). The administration facility unit 101 further includes the functions required for a hospital room or treatment room where hospitalization and medical treatment can be performed, as well as the functions required to improve the livability and quality of life of the subjects who reside there (200 and 300 series).

[0050] The administration facility unit 101 is equipped with a set of functions and equipment (500 series) for medical personnel and related parties to perform tasks related to the administration facility unit 101, located within a space that is locked to restrict entry and exit by the general public.

[0051] As described above, the administration facility unit 101 is transported by the power of the vehicle 102 to the site (such as a parking lot) of an existing facility (hospital) and set up there. The administration facility unit 101 is fixed to the ground by fixing devices (wheel chocks (via the vehicle 102), anchors or outriggers, etc.) as necessary, and used as an actual inpatient facility. Before it can be used, the administration facility unit 101 must have completed the necessary procedures for radiation management.

[0052] The administration facility unit 101 is equipped with a power generation facility, a power storage facility, and / or a facility for receiving power supply. The administration facility unit 101 may perform intake and exhaust via an intake and exhaust facility driven by an external power source instead of the intake and exhaust means 418. To ensure the safety of the patient, the administration facility unit 101 may be equipped with an emergency exit (see FIG. 1) at a location other than the main entrance (especially diagonally from the main entrance or in the patient's main living area, etc.).

[0053] FIG. 1 shows an example in which the administration facility unit 101 is mainly divided into three sections (a rest room 200, an administration room / work room 400, and a management room 500). However, the administration facility unit 101 is not limited to three sections, as long as it is in a radiation controlled area and does not violate the provisions of the Medical Care Act. Examples include an embodiment having four or more sections (for example, an embodiment having two or more rest rooms 200 or administration rooms / work rooms 400), or two sections (for example, an embodiment in which the rest room 200 and the administration room / work room 400 are combined into one section). In one example of the administration facility unit 101, for example, a plurality of rest rooms 200 are connected to one administration room / work room 400 so as to be able to communicate with each other. Also, for example, the rest room 200 may be provided with a plurality of beds 201. Therefore, the administration facility unit 101 may have any combination of compartments, so long as the control room 500 is separated from the rest room 200 and the administration room / work room 400 by the electronic lock 501.

[0054] The administration facility unit 101 is a (transportable) container or trailer house. The floor area inside the administration facility unit 101 is 15 to 40 m. 2 When the vehicle 102 is a large towing vehicle that can travel on public roads, it is necessary to transport the vehicle in a container or trailer house (for example, 15 to 40 m 2 The administration facility unit 101 can be transported in a 15m 2Conventional shielding (concrete or lead) capable of surrounding and covering a space (e.g., a container or trailer house) having a floor area of ​​100 m or more weighs far more than 10 tons. As described above, the administration facility unit 101, which requires only a thin and light shielding (e.g., the wall of a container or trailer house) can be substituted, can be transported by a vehicle capable of running on public roads. From the viewpoint of livability, the internal volume of the administration facility unit 101 is set to 20 to 120 m. 3 It is preferable that:

[0055] The walls of the administration facility unit 101 include a shield. The material of the shield is generally used as a shield for radiation controlled areas, such as lead, tungsten, iron, and concrete. The thickness of the shield selected from the materials is 0.03 mmPb or more, preferably 0.5 mmPb or more, more preferably 1 mmPb or more, in terms of shielding, and 5 cmPb or less, preferably 1 cmPb or less, more preferably 1 mmPb or less, in terms of weight. The lead equivalent and its numerical value are in accordance with the provisions of "Notice of the Director-General of the Pharmaceutical and Medical Sciences Bureau of the Ministry of Health, Labor and Welfare, No. 188, addressed to Prefectural Governors". The exhaust capacity that satisfies the air concentration (dose) in the controlled area is 50 to 500 m 3 / hour, and the exhaust capacity that satisfies the exhaust concentration (dose) outside the controlled area is 1 to 1000 m 3 The effective dose limit at the border of the radiation controlled area within the scope of legal regulations is 1.3 mSv / 3 months, and the effective dose limit at the border of the business establishment is 250 μSv / 3 months.

[0056] For example, when the walls of the administration facility unit 101 where Ac-225 is administered are made of lead with a thickness of 0.3 mm, the exhaust capacity that satisfies the airborne limit (dose) in the controlled area is 92 m 3 / hour, and the exhaust capacity that satisfies the exhaust concentration limit (dose) outside the controlled area is 231 m 3 / hour. In this case, the effective dose at the boundary of the controlled area is 51μSv / 3 months, and the effective dose at the boundary of the business establishment is 215μSv / 3 months, both below the legal standard. When the administration facility unit is 3.4m wide, 12m long, and 2.8m high, the weight of the lead is 0.6t, making it possible to create a unit that can be driven on public roads.

[0057] For example, when the walls of the administration facility unit 101 where Ra-223 is administered are made of lead with a thickness of 5 mm, the exhaust capacity that satisfies the airborne limit (dose) in the controlled area is 214 m 3 / hour, and the exhaust capacity that satisfies the exhaust concentration limit (dose) outside the controlled area is 693 m 3 / hour. In this case, the effective dose at the boundary of the controlled area is 16μSv / 3 months, and the effective dose at the boundary of the business establishment is 64μSv / 3 months, both of which are below the legal standard. When the administration facility unit is 3.4m wide, 12m long, and 2.8m high, the weight of the lead is 9.5t, making it possible to create a unit that can be driven on public roads.

[0058] For example, when the walls of the administration facility unit 101 where Bi-213 is administered are made of lead with a thickness of 0.25 cm, the exhaust capacity that satisfies the airborne limit (dose) in the controlled area is 222 m 3 / hour, and the exhaust capacity that satisfies the exhaust concentration limit (dose) outside the controlled area is 463 m 3 / hour. In this case, the effective dose at the boundary of the controlled area is 47μSv / 3 months, and the effective dose at the boundary of the business establishment is 199μSv / 3 months, both below the legal standard. When the administration facility unit is 3.4m wide, 12m long, and 2.8m high, the weight of the lead is 4.8t, making it possible to create a unit that can be driven on public roads.

[0059] In the administration / work room 400, a substance containing an alpha-emitting radionuclide, which may be a clinical trial drug, an investigational drug, or an approved drug, is administered to a subject or patient. EXAMPLES

[0060] We calculated the shielding thickness and exhaust capacity that would enable the controlled area to achieve an effective dose below the regulatory standard for the facility boundary under the following conditions:

[0061] (conditions) Administration of a substance containing Ac-225 (an alpha-emitting radionuclide) will be carried out in a controlled area. 10MBq (a dose-based single dose) of the substance will be administered to one patient once a week. Only one patient will remain in the controlled area for five consecutive days after administration. The controlled area is 24m 3 It has a volume of (2x2x6m) and the exhaust operation time for exhausting from the controlled area is 2148 hours / 3 months.

[0062] (shielding thickness and exhaust capacity) The walls of the controlled area must be at least 0.3 mm thick when made of lead. The exhaust capacity to meet the airborne limit (dose) within the controlled area is 92 m 3 / hour, and the exhaust capacity that satisfies the exhaust concentration limit (dose) outside the controlled area is 231 m 3 In this case, the effective dose in the controlled area is 51μSv / 3 months, which is below the legal standard for the controlled area boundary as well as the business boundary.

[0063] (others) The walls of waste storage facilities and source storage facilities that need to temporarily or medium-term store unsealed radioactive sources shall be made of 10 mm thick lead. Periodic DOP tests (0.25-0.35 μm dioctyl phthalate particle permeability tests) shall be conducted to confirm that the filters installed in the exhaust system maintain a permeability of 0.001 or less. The above substances (including Ac-225) shall be handled in a fume hood to prevent the volatilization or dissipation of the radioactive sources into the general environment.

[0064] The present invention is not limited to the above-described embodiments (including examples), and various modifications are possible within the scope of the claims. Embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the present invention.

[0065] (summary) [1] A facility unit for administering materials containing radioactive nuclides, comprising: The above substances are radionuclides (a) alpha-emitting radionuclides only, or (b) Contains only alpha-emitting radionuclides and the decay products of those alpha-emitting radionuclides; The administration facility unit is transportable and includes a radiation controlled area and a hospital bed located within the radiation controlled area. Administration facility unit.

[0066] [2] The administration facility unit described in [1], which is a container or a trailer house.

[0067] [3] The above internal floor area is 15 to 40 m 2 The administration facility unit according to [1] or [2],

[0068] [4] An administration facility unit according to any one of [1] to [3], wherein a sign indicating a radioactive controlled area is affixed to the outer surface of the administration facility unit.

[0069] [5] The administration facility unit according to any one of [1] to [4], wherein the substance is a clinical trial drug, an investigational drug, or an approved drug. [Industrial Applicability]

[0070] The present invention may be utilized in the development of therapeutic agents containing radionuclides, in the performance of approval trials of the developed therapeutic agents, and in the treatment of patients with the approved therapeutic agents. [Explanation of symbols]

[0071] 101 Administration Facility Unit 200 Rest room (radioactive control area) 201 beds (hospital beds) 209 Toilet 210 Shower 213 Lighting 214 Outlet 300 Toilet Room 301 On-call facilities 302 Surveillance Camera 400 Administration room / work room (radioactive controlled area) 401 sign 402 Contamination Inspection Room 403 Intake and exhaust vent 404 Draft for handling unsealed radioactive sources 405 Contamination Inspection Equipment 406 Storage 408 Radioactive wastewater storage tank 409 Radioactive wastewater sampling port 410 Radioactive wastewater outlet 413 Business boundary dosimeter 414 Gas Monitor 415 Controlled area boundary dosimeter 416 Storage Room Dosimeter 417 Dosimeter in controlled area 418 Intake and exhaust means 500 Management room 501 Electronic Lock 502 Computer 503 Power receiving equipment 600 Storage room

Claims

1. 1. An administration facility unit for administering a substance containing a radionuclide to a human, comprising: The above substances are radionuclides (a) alpha-emitting radionuclides only, or (b) contains only alpha-emitting radionuclides and the decay products of those alpha-emitting radionuclides; The administration facility unit is provided with a radiation-controlled area and equipment installed within the radiation-controlled area on which a patient can lie, and is transportable in a state in which the administration facility unit is provided with a radiation-controlled area and equipment installed within the radiation-controlled area on which a patient can lie, An administration facility unit, wherein the thickness of the radiation shielding material in the walls of the administration facility unit is greater than or equal to 0.03 mmPb and less than or equal to 5 cmPb in lead equivalent.

2. The administration facility unit according to claim 1 , wherein the facility on which the patient can lie is a simple bed other than a hospital bed or a chair.

3. 3. The administration facility unit according to claim 1 or 2, which is a container or a trailer house.

4. The internal floor space is 15 to 40 m. ２ The administration facility unit according to any one of claims 1 to 3.

5. An administration facility unit as described in any one of claims 1 to 4, wherein an outer surface of the administration facility unit is provided with a sign indicating a radioactive controlled area.

6. The administration facility unit according to any one of claims 1 to 5, wherein the substance is a clinical trial drug, an investigational drug or an approved drug.

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