IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6 Medical Exposure Protection of the Patient Objective To become familiar with the BSS detailed requirement for medical exposure in nuclear medicine: responsibilities, justification, optimization, guidance level, dose constraints accidental exposure and medical records Nuclear Medicine Part 6. Medical Exposure 2 Contents Introduction Responsibilities Justification Optimization of examination Guidance levels of activity Dose constraints Examination of children, pregnant women and lactating women Records Local rules Nuclear Medicine Part 6. Medical Exposure 3 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.1. Introduction Medical Exposure (Definition) “Exposure incurred by patients as part of their own medical or dental diagnosis or treatment; by persons, other than those occupationally exposed, knowingly while voluntarily helping in the support and comfort of patients; and by volunteers in a programme of biomedical research involving their exposure.” Nuclear Medicine Part 6. Medical Exposure 5 Nuclear Medicine Part 6. Medical Exposure 6 Nuclear Medicine Part 6. Medical Exposure 7 Protection from What? Unnecessary examination or treatment (justification) Unnecessary exposure (optimization) Inadequate examinations, which can lead to incorrect or incomplete diagnosis (optimization) Nuclear Medicine Part 6. Medical Exposure 8 Nuclear Medicine Mr. Sharp, I am given to understand that 2 bone scans and a cardiac study done on me have given me 22 mSv whereas 20 mSv is the safe dose. I want to file legal suit against the doctor. What do you feel?? Part 6. Medical Exposure 9 Medical Exposure versus Occupational Nuclear Medicine Part 6. Medical Exposure 10 My resident doctor has got 12 mSv in her last badge report as she was wearing the badge while getting her barium study. She wants off from radiation work. ????? Nuclear Medicine Part 6. Medical Exposure 11 Medical Exposure versus Occupational Exposure Nuclear Medicine Part 6. Medical Exposure 12 While caring for his spouse Mr. Joseph got 2 mSv. As a member of the public with 1 mSv dose limit, he can not get any radiation dose this year. ??????? Nuclear Medicine Part 6. Medical Exposure 13 Medical Exposure (BSS: Interim Edition) • Responsibilities • Justification of medical exposure • Optimization of protection for medical exposure • Guidance levels • Dose constraints • Maximum activity for patients in therapy on discharge from hospital • Investigation of accidental medical exposures • Records Nuclear Medicine Part 6. Medical Exposure 14 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.2. Responsibilities Responsibilities: BSS (2011) “3.149. The regulatory body shall ensure that the authorization for medical exposures to be performed at a particular medical radiation facility allows personnel (radiological medical practitioners, medical physicists, medical radiation technologists and any other health professionals with specific duties in relation to the radiation protection of patients) to take on the responsibilities specified in these Standards only if they: (a) are specialized in the appropriate area; (b) meet the respective requirements for education, training and competence in radiation protection, (c) are named in a list maintained up to date by the registrant or licensee.” Nuclear Medicine Part 6. Medical Exposure 16 Responsibilities: BSS (2011) contd. “3.150. Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic, undergoes a medical exposure unless: (a) The radiological procedure has been requested by a referring medical practitioner and information on the clinical context has been provided, or it is part of an approved health screening programme; (b) The medical exposure has been justified through consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening programme; (c) A radiological medical practitioner has assumed responsibility for protection and safety in the planning and delivery of the medical exposure; (d) The patient or the patient’s legal authorized representative has been informed, as appropriate, of the expected diagnostic or therapeutic benefits of the radiological procedure as well as the radiation risks.” Nuclear Medicine Part 6. Medical Exposure 17 Responsibilities: BSS (2011) contd. “3.153. Registrants and licensees shall ensure that: (a) The radiological medical practitioner performing or overseeing the radiological procedure has assumed responsibility for ensuring overall protection and safety for patients during the planning and delivery of the medical exposure, including the justification of the procedure as required in paras 3.154–3.160 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist as required in paras 3.161–3.176; (b) Radiological medical practitioners, medical physicists, medical radiation technologists and other health professionals with specific duties in relation to protection and safety for patients in a given radiological procedure have the appropriate specialization; (c) Sufficient medical personnel and paramedical personnel are available as specified by the health authority;” . *Interim version of revised BSS Nuclear Medicine Part 6. Medical Exposure 18 Responsibilities: BSS (2011) contd. “(d) For therapeutic uses of radiation, the requirements of these Standards for calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.166, 3.167(c), 3.169 and 3.170, are fulfilled by or under the supervision of a medical physicist; (e) For diagnostic radiological procedures and image guided interventional procedures, the requirements of these Standards for medical imaging, calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.166, 3.167(a), 3.167(b), 3.168, 3.169 and 3.170, are fulfilled by or under the supervision of or with the documented advice of a medical physicist, whose degree of involvement is determined by the complexity of the radiological procedures and the associated radiation risks; (f) Any delegation of responsibilities by a principal party is documented.” Nuclear Medicine Part 6. Medical Exposure 19 Nuclear Medicine Part 6. Medical Exposure 20 FACTORS AFFECTING MEDICAL EXPOSURE Request Examination or treatment Biomedical research Patient identification and information Administration of radiopharmaceutical Child ? Lactating woman ? Pregnant woman ? Safe preparation of prescribed radiopharmaceutical and activity Dose constraints Examination Method Quality of equipment Correct use of equipment Treatment Dose constraints to comforters and visitors Accidental medical exposure Who is responsible? Nuclear Medicine Part 6. Medical Exposure 21 RESPONSIBILITY STRUCTURE Licensee/Hospital management Optimization of medical exposure through organization and resources Nuclear Medicine Department Referring physician Justification of medical exposure Optimization of medical exposure through well educated personnel with clearly defined responsibilities NM specialist Qualified expert NM technologist Nurse Engineer Radiopharmacist Nuclear Medicine Part 6. Medical Exposure 22 Referring Physician Prescribe and justify diagnostic procedures and therapy in writing in co-operation with the nuclear medicine specialist Nuclear Medicine Part 6. Medical Exposure 23 Administrative Manager • Appoint the necessary personnel and ensure the individuals have the necessary education to perform their duties. • Establish a radiation protection programme and provide the necessary resources. • Assign clear responsibilities for personnel. • Appoint a Radiation Protection Officer. • Establish a comprehensive QA programme. • Support education and training of personnel. Nuclear Medicine Part 6. Medical Exposure 24 Nuclear Medicine Staff Individuals with key positions, i.e., responsibilities for protection and safety and those who could substantially affect protection and safety by virtue of tasks involving operation or manipulation of sources, or equipment which could lead to an accidental exposure should have documented evidence of education and training. The objective is to ensure that only qualified personnel fill such positions. In nuclear medicine, these individuals are: Nuclear medicine physicians Qualified experts in nuclear medicine physics (medical physicists) Other health professionals in nuclear medicine (radiopharmacists, nuclear medicine technologists, nurses,…) Radiation Protection Officer Nuclear Medicine Part 6. Medical Exposure 25 Personal Authorization To obtain the personal authorization, the nuclear medicine staff should comply with the following requirements: university degree or equivalent relevant to the profession by the competent education authorities as required in the country; accreditation to exercise the profession granted by the competent authorities or institutions as required in the country; course on radiation protection for which the contents, the methodology and the teaching institution are approved by the Regulatory Authority. This course may be integrated in the curricula of the professional education; and on the job training supervised by professionals with authorization by the Regulatory Authority. Nuclear Medicine Part 6. Medical Exposure 26 Nuclear Medicine Specialist Ensure overall patient protection and safety; provide consultation and clinical evaluation of patients ensure that the exposure of patients be the minimum required to achieve the intended objective; take into account relevant information from previous examinations in order to avoid unnecessary additional examinations; take into account the relevant guidance levels for medical exposure; determine dose prescription for therapy in consultation with the medical physicist; and provide evaluation of any radiation incident and accident from medical point of view. Nuclear Medicine Part 6. Medical Exposure 27 Medical Physicist Participate in continuing review of the nuclear medicine practice’s resources (including budget, equipment, and staffing), operations, and policies and procedures; Develop requirements and specifications for the purchase of appropriate equipment assuring radiation safety; Plan in conjunction with the nuclear medicine physician the facilities for nuclear medicine practice; Carry out acceptance testing; Establish dose calculation procedures in nuclear medicine therapy; Establish and implement QA procedures in nuclear medicine; Supervise equipment maintenance; Investigate and evaluate incidents and accidents. Nuclear Medicine Part 6. Medical Exposure 28 Nuclear Medicine Technologist • Patient identification; • Patient information; • Information to accompanying persons and staff nursing a patient after a nuclear medicine examination or therapy; • Verifying that the female patient is non-pregnant; • Assure that a mother in lactation is given information about discontinuation of nursing; • Make the calculation of administered activity to a child according to the local rules; • Verify the administered radiopharmaceutical and its activity; • Perform regular quality control of activity meter and other relevant equipment; • Perform regular workplace monitoring; • Correct handling of the equipment and safety accessories; • Inform the RPO in the case of accident or incident; • Inform the Nuclear Medicine Physician in the case of misadministrations; • Participate in education and training of new personnel. Nuclear Medicine Part 6. Medical Exposure 29 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.3. Justification Justification Although Nuclear Medicine is a justified diagnostic tool a case-by-case justification shall be applied. This is the responsibility of the referring physician in co-operation with the nuclear medicine specialist and other specialists in diagnostic imaging, taking relevant guidelines into account. Nuclear Medicine Part 6. Medical Exposure 31 Justification :BSS (2011) Relevant parties shall ensure that medical exposures are justified: “3.154. Medical exposures shall be justified by weighing the expected diagnostic or therapeutic benefits that they yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure. 3.155. Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken of advances in knowledge and technological developments.” Nuclear Medicine Part 6. Medical Exposure 32 Justification: BSS (2011) Contd… “3.156. The justification of medical exposure for an individual patient shall be carried out through consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, with account taken, in particular for patients who are pregnant or breast-feeding or paediatric, of: (a) The appropriateness of the request; (b) The urgency of the procedure; (c) The characteristics of the medical exposure; (d) The characteristics of the individual patient; (e) Relevant information from the patient’s previous radiological procedures. 3.157. Relevant national or international referral guidelines shall be taken into account for the justification of the medical exposure of an individual patient in a radiological procedure.” Nuclear Medicine Part 6. Medical Exposure 33 Justification: BSS (2011) contd.. “3.158. Justification for radiological procedures to be performed as part of a health screening programme for asymptomatic populations shall be carried out by the health authority in conjunction with appropriate professional bodies. 3.159. Any radiological procedure on an asymptomatic individual that is intended to be performed for the early detection of disease, but not as part of an approved health screening programme, shall require specific justification for that individual by the radiological medical practitioner and the referring medical practitioner, in accordance with the guidelines of relevant professional bodies or the health authority. As part of this process, the individual shall be informed in advance of the expected benefits, risks and limitations of the procedure.” Nuclear Medicine Part 6. Medical Exposure 34 Justification: BSS (2011) contd… “ 3.160. The medical exposure of volunteers as part of a programme of biomedical research is deemed to be not justified unless: (a) It is in accordance with the provisions of the Helsinki Declaration [20] and takes into account the guidelines published by the Council for International Organizations of Medical Sciences [21], together with the recommendations of the ICRP [22]; (b) It is subject to approval by an ethics committee (or other institutional body that has been assigned similar functions by the relevant authority), subject to any dose constraints that may be specified (as required in paras 3.148(a)(ii) and 3.173), and subject to applicable national regulations and local regulations.” Nuclear Medicine Part 6. Medical Exposure 35 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.4. Optimization of Examination Otimization of Patient Examination Diagnostic Objective Nuclear Medicine Part 6. Medical Exposure Medical Exposure 37 Optimization of Medical Exposure in Nuclear Medicine “3.162. For diagnostic radiological procedures and image guided interventional procedures, the radiological medical practitioner, in cooperation with the medical radiation technologist and the medical physicist, and if appropriate with the radiopharmacist or radiochemist , shall ensure that the following are used: (a) Appropriate medical radiological equipment and software and also, for nuclear medicine, appropriate radiopharmaceuticals; (b) Appropriate techniques and parameters to deliver a medical exposure of the patient that is the minimum necessary to fulfil the clinical purpose of the procedure, with account taken of relevant norms of acceptable image quality established by relevant professional bodies and relevant diagnostic reference levels established in accordance with paras 3.147 and 3.168.” Nuclear Medicine Part 6. Medical Exposure 38 Optimization contd... “3.163. For therapeutic radiological procedures, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, shall ensure that for each patient the exposure of volumes other than the planning target volume is kept as low as reasonably achievable consistent with delivery of the prescribed dose to the planning target volume within the required tolerances. 3.164. For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that for each patient the appropriate radiopharmaceutical with the appropriate activity is selected and administered so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.” Nuclear Medicine Part 6. Medical Exposure 39 Optimization contd... “3.165. Registrants and licensees shall ensure that the particular aspects of medical exposures are considered in the optimization process for: (a) Paediatric patients subject to medical exposure; (b) Individuals subject to medical exposure as part of a health screening programme; (c) Volunteers subject to medical exposure as part of a programme of biomedical research; (d) Relatively high doses to the patient; (e) Exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant woman is exposed to the useful radiation beam or could otherwise receive a significant dose; (f) Exposure of a breast-fed infant as a result of a female patient undergoing a radiological procedure with radiopharmaceuticals. Nuclear Medicine Part 6. Medical Exposure 40 Optimization of Medical Exposure Radionuclide Biokinetics Patient Administered activity Nuclear Medicine Effective dose Quality of equipment etc Radiation risk Image quality Part 6. Medical Exposure 41 Radiopharmaceuticals Considering that, according to the BSS, the activities listed below also require authorization, regulatory authorities may require the licensee of a nuclear medicine practice to contract any of the following services only to enterprises authorized by the Regulatory Authority: production, import, distribution, sale or transfer of radioactive sources personal monitoring installation, maintenance of nuclear medicine equipment disposal of radioactive sources Use only radiopharmaceuticals from an authorized manufacturer! Nuclear Medicine Part 6. Medical Exposure 42 Radiopharmaceuticals If more than one radiopharmaceutical can be used for a procedure consideration should be given to physical, chemical and biological properties. Example: Leucocytes labelled with In-111 0.36 mSv/MBq 20 MBq 7.2 mSv T1/2 = 2.8 days Nuclear Medicine Tc-99m 0.011 mSv/MBq 200 MBq 2.2 mSv T1/2 = 6 hours Part 6. Medical Exposure 43 Radiopharmaceuticals Tl-201 25 mSv Nuclear Medicine Tc-99m 8 mSv Part 6. Medical Exposure 44 Optimization of Image Quality Image quality depends on: Administered activity Technical factors - equipment used - acquisition protocol - image processing & evaluation - noise - spatial resolution - scatter Patient factors - size - age - disease - movement Nuclear Medicine Part 6. Medical Exposure 45 Optimization of Administered Activity In general, doses should be maintained as low as reasonable achievable but high enough to obtain the desired diagnostic information. This means that exposures above clinically acceptable maximum doses must be avoided as well as doses below clinically acceptable minimum doses Nuclear Medicine Part 6. Medical Exposure 46 Optimization of Administered Activity Value of diagnostic information There is a threshold below which no useful information can be expected Above this threshold the diagnostic quality increases steeply with the administered activity Once an acceptable level has been reached further increase of activity will not improve the result Administered activity Nuclear Medicine Part 6. Medical Exposure (ICRP 52) 47 Administered Activity to Children Optimization is Necessary! Administered activity (MBq) 120 100 80 60 40 20 0 0 4 8 12 16 20 24 Age (years) Administered activity to children referred to DMSA scan in Swedish hospitals Nuclear Medicine Part 6. Medical Exposure 48 …..noting the special requirements for patients with impairment of Organ Function Kidney dose (mGy) KIDNEY FUNCTION (100 MBq Tc99m-DTPA) 50 40 30 20 10 0 1 normal function Nuclear Medicine 2 3 partially obstructed outflow Part 6. Medical Exposure 4 obstructed totally outflow 49 Optimization (ii) use of methods for blocking the uptake in organs not under study and for accelerated excretion when applicable; • Blocking agents for thyroid • Hydration and frequent voiding of the urinary bladder • Laxatives • Catheterisation to empty the bladder??? • Cholecystokinin (fatty meal) for gallbladder emptying Nuclear Medicine Part 6. Medical Exposure 50 Tc-99m-MAG3, Two different first voiding times, girl 7 years Time between injection and first void Organ 30 min Bladder wall (mGy/MBq) Nuclear Medicine 2 hours 2h/30min 0,07 0,15 2,1 Gall bladder wall 0,099 0,01 1,0 Kidneys 0,0078 0,0081 1,0 Liver 0,0018 0,002 1,1 Red marrow 0,0018 0,0022 1,2 Ovaries 0,005 0,0086 1,7 Testes 0,0045 0,0082 1,8 Effective dose (mSv/MBq) (Eleonor Westergren) 0,0062 0,011 1,8 Part 6. Medical Exposure 51 Optimization (iii) appropriate image acquisition and processing; Equipment used: •Single head/dual head camera •Collimator used Nuclear Medicine Part 6. Medical Exposure 52 Aquisition Protocol Static? Tomographic? Dynamic? Nuclear Medicine Part 6. Medical Exposure 53 Acquisition Protocol Static imaging Dynamic imaging Tomographic imaging Nuclear Medicine - matrix size - number of counts - projections, zoom - matrix size - time/frame - number of groups - 180o or 360o - matrix size - number of angles - time/angle Part 6. Medical Exposure 54 Image Processing & Evaluation Static Dynamic Tomographic Nuclear Medicine - smoothing - image filtering - quantification - applications programme - regions of interest (ROI) - time-activity curves - application programme - attenuation correction - reconstruction method - image filtering - slices displayed - application programme Part 6. Medical Exposure 55 Noise Random variations in the number of counts (N) in a pixel, ROI or in a point in a time-activity curve true uptakes may not be seen false uptakes may occur uncertainty in quantitative values Lower noise requires more administered activity or longer acquisition times Noise Nuclear Medicine 100 N SD % Part 6. Medical Exposure 56 Noise 1000000 counts Nuclear Medicine Part 6. Medical Exposure 100000 counts 57 Phantom: Different number of counts 50 k Nuclear Medicine 250 k Part 6. Medical Exposure 1000 k 58 Thyroid Scintigraphy, different acquisition times 1 min 2 min 4 min 8 min Nuclear Medicine Part 6. Medical Exposure 59 The noise level versus activity levels for an adult, CBF 9 8 7 CV (%) 6 5 4 3 2 1 0 0 500 1000 1500 2000 2500 3000 3500 4000 Activity (MBq) Eleonor Westergren Nuclear Medicine Part 6. Medical Exposure 60 Spatial Resolution Describes how a point source is reproduced small details are not seen uptakes seem to be lower Improved spatial resolution can be achieved by changing to a collimator with higher resolution but: lower sensitivity requires more administered activity or longer acquisition times Nuclear Medicine Part 6. Medical Exposure 61 Appropriate Image Acquisition Close Nuclear Medicine 15 cm Part 6. Medical Exposure Wrong setting of energy window 62 Patient Factors Size increased scatter spatial resolution Age & Disease radiopharmaceutical distribution movement artifacts Nuclear Medicine Part 6. Medical Exposure 63 Image Quality Patient Movement Movement Nuclear Medicine Corrected Part 6. Medical Exposure 64 Staff and Procedures •Well trained staff with access to manuals and other documentation. • Quality control program. • Regular maintenance of equipment Nuclear Medicine Part 6. Medical Exposure 65 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.5. Reference Levels of Activity Diagnostic Reference Levels (BSS) “3.168. Registrants and licensees shall ensure that: (a) Local assessments, on the basis of the measurements required in para. 3.167, are made at approved intervals for those radiological procedures for which diagnostic reference levels have been established (para. 3.147); (b) A review is conducted to determine whether the optimization of protection and safety for patients is adequate, or whether corrective action is required if, for a given radiological procedure: (i) typical doses or activities exceed the relevant diagnostic reference level; or (ii) typical doses or activities fall substantially below the relevant diagnostic reference level and the exposures do not provide useful diagnostic information or do not yield the expected medical benefit to the patient.” Nuclear Medicine Part 6. Medical Exposure 67 Reference Levels of Activity Examination Bone scan Brain scan CBF Thyroid imaging Thyroid imaging Parathyroid Lung perfusion Lung ventilation Lung ventilation Lung ventilation Liver & spleen Myocardium Myocardium Kidneys Kidneys Kidneys Tumours Tumour Tumour Nuclear Medicine Radionuclide Chemical form Tc-99m Tc-99m Tc-99m Tc-99m I-123 Tl-201 Tc-99m Tc-99m Kr-81m Xe-133 Tc-99m Tl-201 Tc-99m Tc-99m Tc-99m I-123 Ga-67 I-123 I-131 phosphonate pertechnetate HMPAO pertechnetate iodide chloride MAA aerosol gas gas colloid chloride isonitriles DMSA DTPA hippuran citrate MIBG MIBG Part 6. Medical Exposure Guidance level (MBq) 600 500 500 200 20 80 100 80 6000 400 80 100 600 160 350 20 300 400 20 Effective dose (mSv) 4.8 2.7 5.5 2.6 3.4 18 1.2 0.6 0.2 0.4 0.6 23 4.2 2.5 2.2 0.3 36 7.2 4 68 Reference Levels How to establish: 1. Elimination of outliers 2. State-of-the practice (good practice) 3. State-of-the art (optimal practice) Nuclear Medicine Part 6. Medical Exposure 69 Distribution of Administered Activities Log-normal distributions Number of patients Activity Optimized? Guidance level Nuclear Medicine Part 6. Medical Exposure 70 Activity, MBq 900 Max 800 700 IAEA guidance level 600 Mean and range of mean (Sweden, 1995) 500 400 Optimized? 300 200 100 0 0 1 Bone scintigraphy Nuclear Medicine Part 6. Medical Exposure 71 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.6. Dose Constraints: Volunteers and Comforters Dose Constraints “3.151. Registrants and licensees shall ensure that no individual incurs a medical exposure as part of a programme of biomedical research unless the exposure has been approved by an ethics committee (or other institutional body that has been assigned similar functions by the relevant authority) as required in para. 3.160 and a radiological medical practitioner has assumed responsibility as specified in para. 3.153(a). Registrants and licensees shall ensure that the requirements specified in para. 3.173 are met for the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.” Nuclear Medicine Part 6. Medical Exposure 73 Biomedical Research ICRP and WHO categorization of risk Trivial Risk Category: I I.A. I. III Total detriment ~ 10-6 or less ~ 10-5 ~ 10-4 ~ 10-3 or more Range of effective doses (adults), mSv < 0.1 0.1 - 1 1 - 10 > 10a Anticipated level of benefit to Society Minor Intermediate to moderate a Minor to Intermediate Moderate Level of Risk: Substantial To be kept below deterministic thresholds except for therapeutic experiments. Nuclear Medicine Part 6. Medical Exposure 74 Research on Pregnant Patients Radiation research involving pregnant patients should be discouraged Nuclear Medicine Part 6. Medical Exposure 75 Dose Constraints “3.152. Registrants and licensees shall ensure that no individual incurs a medical exposure as a carer or comforter unless he or she has received, and has indicated an understanding of, relevant information on radiation protection and information on the radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure. Registrants and licensees shall ensure that the requirements specified in para. 3.172 are met for the optimization of protection and safety for any procedure in which an individual acts as a carer or comforter.” Nuclear Medicine Part 6. Medical Exposure 76 Dose Constraints ..The dose shall be constrained so that it is unlikely that his or her dose will exceed 5 mSv during the period of a patient’s diagnostic examination or treatment. The dose to children visiting patients who have ingested radioactive materials should be similarly constrained to less than 1 mSv Nuclear Medicine Part 6. Medical Exposure 77 NM patient with pregnant family member at home For most diagnostic nuclear medicine procedures, the total decay dose at 0.5 meter from the patient ranges from .02-0.25 mGy and at 1 meter from the patient the dose is 0.05-0.10 mGy. This poses no significant risk to pregnant family members. Nuclear Medicine Part 6. Medical Exposure 78 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.7. Examination of Children, Pregnant and Lactating Women Optimization “3.165. Registrants and licensees shall ensure that the particular aspects of medical exposures are considered in the optimization process for: (a) Paediatric patients subject to medical exposure; …….. (e) Exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant woman is exposed to the useful radiation beam or could otherwise receive a significant dose; (f) Exposure of a breast-fed infant as a result of a female patient undergoing a radiological procedure with radiopharmaceuticals.” Nuclear Medicine Part 6. Medical Exposure 80 Nuclear Medicine Part 6. Medical Exposure 81 Radiation Risks 16 LIFE-TIME RISK (%/Sv) 14 12 10 8 6 4 2 0 0 5 15 25 35 45 55 65 75 85 95 AGE AT EXPOSURE Nuclear Medicine Part 6. Medical Exposure 82 Activity to Children The amount of activity administered to an adult can for children be reduced by one of the following methods: Nuclear Medicine body weight/70 kg body surface area/1.73 m2 height/174 cm Part 6. Medical Exposure 83 Fraction of the Adult Activity Fraction of adult activity 1,2 1,0 0,8 0,6 BW H BSA 0,4 0,2 0,0 0 Nuclear Medicine 4 8 12 Age (years) Part 6. Medical Exposure 16 20 24 84 European Association of Nuclear Medicine (EANM) 1 Fraction of adult activity 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 0 10 20 30 40 50 60 Body Weight (kg) Nuclear Medicine Part 6. Medical Exposure 85 …...noting the special requirements for Children Local rules for administered activities to children should be available. Recommendations from international professional organizations should be followed. Nuclear Medicine Part 6. Medical Exposure 86 Pregnancy Nuclear Medicine Part 6. Medical Exposure 87 Example of justified use of CT in a pregnant female who was in a motor vehicle accident ribs Fetal skull Blood outside uterus Fetal dose 20 mGy Nuclear Medicine Part 6. Medical Exposure 88 3 minute CT exam and taken to the operating room. She and the child survived Free blood Kidney ripped off aorta (no contrast in it) Nuclear Medicine Part 6. Medical Exposure Splenic laceration 89 Introduction Thousands of pregnant women are exposed to ionizing radiation each year Lack of knowledge is responsible for great anxiety and probably unnecessary termination of pregnancies For most patients, radiation exposure is medically appropriate and the radiation risk is minimal Nuclear Medicine Part 6. Medical Exposure 90 In some circumstances, the exposure is inappropriate and the unborn child may be at increased risk. Prenatal doses from most properly done diagnostic procedures present no measurably increased risk of prenatal death, malformation, mental impairment. Higher doses such as those from therapeutic procedures can result in significant fetal harm. Nuclear Medicine Part 6. Medical Exposure 91 An example of media nonsense Nuclear Medicine Part 6. Medical Exposure 92 Pregnant Women “3.175. Registrants and licensees shall ensure that there are procedures in place for ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus, so that this information can be considered in the justification for the radiological procedure (para. 3.154) and in the optimization of protection and safety (para. 3.165).” Nuclear Medicine Part 6. Medical Exposure 93 Situation Analysis Number of females getting exposed every week without knowing that they are pregnant: Inadvertent radiation exposure of early conceptus Planned Exposures: patients needing nuclear medicine examinations or even therapy while pregnant Accidental exposure in pregnancy Occupational exposures in pregnancy Exposure of female of reproductive capacity Nuclear Medicine Part 6. Medical Exposure 94 How Sensitive is Early Conceptus? Threshold dose deterministic effects 100 - 200 mSv Mental retardation 40 % /Sv Cancer and leukemia before 10 years of age lifetime 2 % /Sv 15 % /Sv Hereditary effects 1 % /Sv Nuclear Medicine Part 6. Medical Exposure 95 Irradiation of Fetus Results from: Placental transfer distribution of activity in fetal organs not much data available I-131 as iodide Tc-99m pertechnetate External radiation from activity present in the mothers organs and tissues radiopharmaceuticals eliminated via the kidneys Nuclear Medicine Part 6. Medical Exposure 96 Absorbed Dose to the Fetus Examination fetus Bone (Tc99m) Brain (CBF) Lung (Tc99m-MAA) Kidneys (MAG3) Tumour or abscess (Ga-67 citrate) Heart (Tc99m-MIBI) Heart (Tl-201) Thyroid (Tc99m) Thyroid (I-131) Activity Dose to (MBq) (mSv) 600 500 160 100 300 300 100 100 100 4 4 0.4 2 28 5 10 1 7 4 0.02 Kidney clearance (Cr-51-EDTA) (Data from Russell, Stabin et al Radiation dose to the embryo/fetus from radiopharmaceuticals Draft, 1997 Nuclear Medicine Part 6. Medical Exposure 97 Absorbed Dose to the Fetus 0,3 I-131 iodide Tc-99m-MAG3 mGy/MBq 0,2 0,1 0,0 Early 3 months 6 months 9 months Pregnancy month (Data from Russell, Stabin et al Radiation dose to the embryo/fetus from radiopharmaceuticals Draft, 1997 Nuclear Medicine Part 6. Medical Exposure 98 Risk of childhood cancer from mother’s diagnostic procedure in NM The risk to an embryo or fetus from absorbing 1 mSv of radiation dose - an increased risk of developing childhood cancer of 6 in 100,000 (3 of which would be fatal) Natural risk of complications of pregnancy or of birth anomalies is approximately 4,000 in 100,000 Natural risk of the incidence of childhood cancer – 150 in 100,000 Fetal doses from diagnostic procedures in NM – max. tens of mSv ( 67Ga, 131I) Nuclear Medicine Part 6. Medical Exposure 99 Prevention of Inadvertent Exposure in Pregnancy When a female of reproductive age presents for an examination ask: Is she likely to be pregnant? Is period over-due? This should be recorded at appropriate place in the form Females under 16? Depending upon answer No possibility of pregnancy Proceed with the examination Nuclear Medicine Part 6. Medical Exposure 100 IF YOU THINK THAT YOU MIGHT BE PREGNANT , NOTIFY STAFF BEFORE TREATMENT Nuclear Medicine Part 6. Medical Exposure 103 Before Examination is Performed •Many patients incorrectly assume that irradiation from a nuclear medicine examination begins when the gamma camera begins imaging, •Therefore, before radiopharmaceutical administration, it is necessary to consider as pregnant any woman of reproductive age presenting for a nuclear medicine examination at a time when a menstrual period is overdue or missed, unless •there is information that precludes pregnancy (e.g., hysterectomy or tubal ligation). •If the menstrual cycle is irregular, and a non-technetium or therapeutic radiopharmaceutical is being administered, a pregnancy test may be indicated before proceeding. Nuclear Medicine Part 6. Medical Exposure 104 Informed Consent and Understanding The pregnant patient has a right to know the magnitude and type of potential radiation effects that might result from in-utero exposure Communication should be related to the level of risk. Verbal communication may be adequate for low dose procedures. If fetal doses are above 1 mGy, usually a more detailed explanation is given Nuclear Medicine Part 6. Medical Exposure 105 If an examination of a pregnant woman is judged to be necessary Choice of radiopharmaceutical Is it possible to reduce the administered activity? Prolonged acquisition times? For radiopharmaceuticals eliminated via the kidneys: Partially filled urinary bladder at the time of administration Hydration and frequent voiding Nuclear Medicine Part 6. Medical Exposure 106 During the Examination Using smaller administered activities and longer imaging times can reduce the absorbed dose to the fetus. This is feasible if the patient is not too sick and is able to remain still Nuclear Medicine Part 6. Medical Exposure 107 During the Examination The sequence of the examinations can be adjusted to reduce radiation dose. •e.g. a ventilation-perfusion lung scan ordered on a pregnant patient to exclude a pulmonary embolus. • Many laboratories will perform the ventilation scan first and then do the perfusion scan. •In the specific case of a suspected pulmonary embolus, the perfusion scan can be performed first, and if it is normal, a ventilation scan is not needed at all. Nuclear Medicine Part 6. Medical Exposure 108 During the Examination (contd.) • There will be much smaller fetal dose with Xenon-133 • If one does ventilation scans using 99mTc-DTPA aerosol, this will be absorbed and excreted via the kidneys, and while in the bladder it will contribute to fetal dose Nuclear Medicine Part 6. Medical Exposure 109 Dose reduction after procedure has been performed Can the dose be reduced after the procedure has been performed? • Yes, by accelerating voiding, bladder dose • Not possible in radiology and RT Nuclear Medicine Part 6. Medical Exposure 110 Termination of Pregnancy Termination of pregnancy at fetal doses of less than 100 mGy is NOT justified based upon radiation risk At fetal doses in excess of 100 mGy, there can be fetal damage, the magnitude and type of which is a function of dose and stage of pregnancy In these cases decisions should be based upon individual circumstances Nuclear Medicine Part 6. Medical Exposure 111 Becoming Pregnant after Irradiation • ICRP has recommended that a woman not become pregnant until the potential fetal dose from remaining radionuclides is less than 1 mGy. • This is not usually a consideration except for radiopharmaceuticals labelled with 59Fe (for metabolism studies) or 75Se (for adrenal imaging). • As a result of the long physical half-lives of these radionuclides and their long residence times in the body, it is recommended that pregnancy be avoided for 6 and 12 months respectively. Nuclear Medicine Part 6. Medical Exposure 112 Nuclear Medicine Part 6. Medical Exposure 113 Mothers in Lactation Nuclear Medicine Part 6. Medical Exposure 114 Optimization: Breast Feeding “3.176. Registrants and licensees shall ensure that there are arrangements in place for establishing that a female patient is not breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to an infant being breast-fed, so that this information can be considered in the justification for the radiological procedure (para. 3.154 and 3.156 ) and in the optimization of protection and safety (para. 3.165).” Nuclear Medicine Part 6. Medical Exposure 115 Irradiation of breastfed child results from: Nuclear Medicine Activity in milk External radiation from the mother Possible contamination Part 6. Medical Exposure 116 Recommendations for Cessation of Breast Feeding Radiopharmaceutical Tc -99m DTPA Tc -99m MAA Tc -99m Pertechnetate Tc -99m DISIDA Tc -99m glucoheptonate Tc -99m HAM Tc -99m MIBI Tc -99m MDP Tc -99m PYP Tc -99m RBC's in vivo labelling Tc -99m RBC's in vitro labelling Tc -99m Sulphur Colloid Tc -99m DTPA Aerosol Tc -99m WBC's Tc -99m MAG3 Nuclear Medicine Administered activity (MBq) 740 148 185 300 740 300 1110 740 740 740 Counseling? 740 no 444 37 185 370 no no yes no Part 6. Medical Exposure no yes yes no no no no no no yes Advice 12 hr 4 hr 12 hr 48 hr 117 Recommendations for Cessation of Breast Feeding Radiopharmaceutical Ga-67 Citrate I-131 NaI Cr-51 EDTA In-111 WBC's I-123 NaI I-123 OIH I-123 mIBG I-125 OIH I-131 OIH Tl-201 Xe-133 gas Nuclear Medicine Administered activity (MBq) 185 5550 1.85 20 15 74 370 0.37 11.1 111 Part 6. Medical Exposure Counseling? Advice yes yes no no yes no yes no no yes no Cessation Cessation Cessation 48 hr 96 hr 118 IF YOU ARE BREASTFEEDING, PLEASE NOTIFY THE STAFF Nuclear Medicine Part 6. Medical Exposure 119 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.8. Records Records “3.182. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following personnel records: (a) Records of any delegation of responsibilities by principal parties (as required in para. 3.153(f)); (b) Records of training of personnel in radiation protection (as required in para. 3.149(b)). 3.183. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records of calibration, dosimetry and quality assurance: (a) Records of the results of the calibrations and periodic checks of the relevant physical and clinical parameters selected during treatment of patients; (b) Records of dosimetry of patients, as required in para. 3.167; (c) Records of local assessments and reviews made with regard to diagnostic reference levels, as required in para. 3.168; (d) Records associated with the quality assurance programme, as required in para. 3.170(d).” Nuclear Medicine Part 6. Medical Exposure 121 Records “3.184. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records for medical exposure: ……. (c) For nuclear medicine, the types of radiopharmaceutical administered and their activity; ……. (e) Exposure records for volunteers subject to medical exposure as part of a programme of biomedical research; (f) Reports on investigations of unintended and accidental medical exposures (as required in para. 3.180(d).” Nuclear Medicine Part 6. Medical Exposure 122 Records and Documents: Medical Exposures •Administered radiopharmaceutical and activity (each patient) •Route of administration (each patient) •Incident and accident investigation reports •Absorbed doses to patients •Calibration certificate (activity meter) •Quality control of equipment (gamma camera & activity meter) •Maintenance and repair work •Audits and reviews of radiation safety programme •Training provided: initial refresher Nuclear Medicine Part 6. Medical Exposure 123 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 6. Medical Exposure Protection of the Patient Module 6.9. Local Rules Local Rules: Medical Exposures Activity to adults in nuclear medicine examinations Activity to children in nuclear medicine examinations Rules for pregnant women Rules for lactating women Preparation and dispensation of radiopharmaceuticals Procedure manual, activity meter Patient identification and information Administration of radiopharmaceuticals Procedure manual, gamma camera examinations Procedures in case of misadministrations Procedures in case of accidents Records Nuclear Medicine Part 6. Medical Exposure 125 Local Rules Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT Nuclear Medicine Activity to Adults Children & Young people Pregnant women Lactating women Radiopharmaceuticals Activity measurement Misadministration Examination Proceedure Manuals Patient Identification Part 6. Medical Exposure 126 Questions? Nuclear Medicine Part 6. Medical Exposure 127 Disccussion • Increase the activity for elderly patients and patients with pain to reduce the examination time? • Increase the activity for all patients in order to increase the throughput of patients? • Increase the activity for paediatric patients in order to avoid sedation or general anaesthesia? • Increase the activity to cancer patients who are nevertheless going to receive radiotherapy? Nuclear Medicine Part 6. Medical Exposure 128 Discussion A patient is referred to a bone scan. It is obvious from the information on the request that this is the wrong type of examination to get the right diagnosis. The examination is done anyway. Who is responsible for this non justified exposure? Nuclear Medicine Part 6. Medical Exposure 129 Discussion Discuss how to handle the problem when it is necessary to to examine or treat a woman who is pregnant. Nuclear Medicine Part 6. Medical Exposure 130 Where to Get More Information Other sessions Further readings Part 7 Optimization of protection in Nuclear Medicine Examinations Part 8 Optimization of protection in Nuclear Medicine therapy Part 11 Potential exposure and accidental medical exposure IAEA Basic Safety Standards: Interim Edition (2011) IAEA Safety Guide on Radiological Protection for Medical Exposure IAEA Model regulations on radiation safety in nuclear medicine WHO. Manual on Radiation Protection in Hospitals and General Practices. Volume 4: Nuclear Medicine ICRP publication 84 Practical session Simulated inspection Nuclear Medicine Part 6. Medical Exposure 131 Local Rules 1 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT ADULTS Examination Bone scan Radiopharmaceutical Activity (MBq) Tc99m DPD 400 Thyroid Tc99m-pertechnetate 100 Kidney Tc99m-MAG3 75 Note: For not listed examinations consult the nuclear medicine specialist Nuclear Medicine Part 6. Medical Exposure 132 Local Rules 2 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT CHILDREN & YOUNG PEOPLE Examination Bone scan Radiopharmaceutical Tc99m DPD Activity (MBq) Age 0-14 Age 15-18 BW x 3 BW x 6 Thyroid Tc99m-pertechnetate BW x 0.5 BW x 1 Kidney Tc99m-MAG3 BW x 0.5 BW x 1 Note: For not listed examinations consult the nuclear medicine specialist Nuclear Medicine Part 6. Medical Exposure 133 Local Rules 3 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT PREGNANT WOMEN •If a female patient is pregnant or think that she might be, the responsible physician shall always make a decision whether the examination shall be done or shall be postponed either until after delivery or to the latter half of the pregnancy, carefully considering the use of other diagnostic methods. • If there is uncertainty concerning pregnancy, either because the period is known to be overdue or for other reasons, the woman shall be treated as pregnant until otherwise proved. • The administered activity shall be in proportion to body weight using 70% of the normal adult activity for the required examination Nuclear Medicine Part 6. Medical Exposure 134 Local Rules 4 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT LACTATING WOMEN No counseling of breastfeeding for the following radiopharmaceuticals: 51Cr-EDTA, 99mTc-DMSA, 99mTc-DTPA, 99mTc-MDP, 99mTc-glycoheptonate 99mTc-HMPAO, 99mTc-MIBI, 99mTc-colloids, 99mTc-MAG3(<100MBq), 201Tl-chloride (<80MBq) and 111In-leucocytes (<20MBq). table For other radiopharmaceuticals, see attached For not listed radiopharmaceuticals, consult the nuclear medicine specialist Nuclear Medicine Part 6. Medical Exposure 135 Local Rules 4:1 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT LACTATING WOMEN Counseling of breastfeeding Radiopharmaceutical 99mTc-pertechnetate 4h 99mTc-MAA 12h 201Tl-chloride 96h 67Ga-citrate Cessation ……… Nuclear Medicine Advice ….. Part 6. Medical Exposure 136 Local Rules 5 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT RADIOPHARMACEUTICALS Preparation Dispensing Injection Nuclear Medicine Part 6. Medical Exposure 137 Local Rules 5:1 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT PREPARATION OF RADIOPHARMACEUTICALS Name: DPD (CIS bio) Composition 13 mg 3,3-diphosphono-1,2-propanedicarboxylic acid, tetrasodium salt (DPD) 0.23 mg tin(II)oxide Usage: Bone scintigraphy Preparation: Use a transparent vial shield. Put the kit vial in the shield. Dispense 5 ml pertechnetate (3000 MBq) in a shielded syringe. Add the solution to the vial containing the freeze dried kit. Remove an equal volume of gas to equalize the pressure. Shake the vial gently for 10 s. Store the preparation for 5 min. Temporarily remove the vial from the shield and measure the activity. Use a forceps when moving the vial. Put a label on the shield. The label shall contain: Name of radiopharmaceutical, activity and activity concentration as well as date and time. Check the label against the vial. Same radiopharmaceutical? Record the preparation and sign. The preparation can be used for 5 patient examinations within 6 h from time of preparation. Storage: Kit in fridge Radiopharmaceutical in the shielded container and protected from light Nuclear Medicine Part 6. Medical Exposure 138 Local Rules 5:2 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT DISPENSING RADIOPHARMACEUTICALS 1. 2. 3. 4. 5. Check the label on the vial shield. Is it the required radiopharmaceutical? Calculate the volume to dispense from the decay corrected activity concentration and the requested activity for the intended examination. Dispense the calculated volume using a shielded syringe. Temporarily remove the syringe shield and measure the activity. Write a label and put it on the syringe shield. The label shall contain patient name and id number, radiopharmaceutical, activity, date and time. The label shall be signed. Nuclear Medicine Part 6. Medical Exposure 139 Local Rules 5:3 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT IDENTIFICATION OF PATIENT INJECTION OF RADIOPHARMACEUTICALS 1. 2. 3. 4. 5. 6. 7. 8. 9. Ask the patient about name and birth date or identification number. Ask a female patient about pregnancy. Ask a female patient if she is breastfeeding a child. If necessary, inform the patient about any restrictions according to the local rules. Read the request Check the label on the syringe shield. Is it the correct radiopharmaceutical and activity for the requested examination? Inject according to the local rules for intravenous injections The radiopharmaceutical and the injected activity.shall be recorded Nuclear Medicine Part 6. Medical Exposure 140 Local Rules 6 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT ACTIVITY MEASUREMENT The activity of the radiopharmaceutical shall always be measured after preparation and before and after injection. 1. 2. 3. 4. 5. 6. Select the isotope Check the background reading and make a background adjustment Put the syringe or the vial in the holder using a forceps Put the holder into the chamber Read the activity Remove the holder and put the syringe or vial back into the shield Nuclear Medicine Part 6. Medical Exposure 141 Local Rules 7 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT MISADMINISTRATION The following are defined as misadministrations: Administration to the wrong patient, administration of the wrong radiopharmaceutical, administration of wrong activity (>15% from prescribed activity in therapy and >75% in diagnostic examinations) and wrong route of administration. In case of misadministration: 1. 2. 3. 4. 5. 6. Inform the nuclear medicine specialist Inform the patient and the referring physician Inform the medical physicist (phone ……), who shall calculate and report the patient dose The responsible technician shall write a report about the event and try to explain the causes. The nuclear medicine specialist shall send the report to the Head of the Department who shall decide if the event shall be reported to the authorities. All members of the staff shall be informed Nuclear Medicine Part 6. Medical Exposure 142 Local Rules 8 Department of Nuclear Medicine Radiation Protection Manual PROTECTION OF THE PATIENT Study name: Preparation of patient: Radiopharmaceutical: Route of administration: Activity: Start of measurement: Type of examination: Views: Scanning speed: Collimator: Window setting: Positioning of patient: Presentation of result: Nuclear Medicine Bone scan Empty bladder Tc99m-DPD iv injection 400 MBq 3h post injection Whole body scan AP, PA 10 cm/min LEHR 140+/-20% keV Supine Images in BW on film. Part 6. Medical Exposure 143