IAEA Training Material on Radiation Protection in Nuclear Medicine Part 8 Radiation Protection in Radionuclide Therapy Objective To be able to apply the principle of optimization of radiation protection to therapeutic procedures including design, operational consideration, quality control and clinical dosimetry. Nuclear Medicine Part 8. Therapy 2 Contents Basic requirements Administration of therapy The radioactive patient. Dose constraints The hospitalized patient Emergency procedures Nuclear Medicine Part 8. Therapy 3 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 8 Optimization of Protection in Medical Exposure Module 8.1 Basic Requirements Justification of Medical Exposure (BSS: Interim Edition, 2011) “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.” Use WHO guidelines Nuclear Medicine Part 8. Therapy 5 Responsibilities (BSS: Interim Edition) ”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 8. Therapy 6 Dosimetry (BSS: Interim Edition) “3.167. Registrants and licensees shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and following internationally accepted or nationally accepted protocols, including dosimetry to determine the following: Nuclear Medicine ….. (c) For therapeutic medical exposures, absorbed doses to the tissues or organs for individual patients, as determined to be relevant by the radiological medical practitioner.” Part 8. Therapy 7 Medical Physicist A qualified medical physicist should be responsible for measurement of radionuclide activity, identification of radionuclides and internal radiation dosimetry Nuclear Medicine Part 8. Therapy 8 Absorbed Dose-Administered Activity I-131 Example of method to calculate administered activity from Prescribed absorbed dose to the thyroid Thyroid mass (g) Prescibed dose (Gy) 30 100 Activity (MBq)= Uptake measurements Time (h) 0 2 24 48 144 Standard (cpm) 21736 18286 17165 13171 Patient (cpm) 5521 12338 10565 5754 Bg (cpm) 100 100 100 100 Effective half-life (d): Activity to administer (MBq): Uptake (%) 73,5 25,1 67,3 61,3 43,3 23.4*mass(g)*dose (Gy) uptake at t=0 (%)*Teff (d) 4,0 240 Berg GEB et al, J Nucl Med 1996; 37:228-232 Nuclear Medicine Part 8. Therapy 9 Uptake Measurement Nuclear Medicine Part 8. Therapy 10 Gamma Camera Examination Nuclear Medicine Part 8. Therapy 11 Gamma Camera Examination Used to determine the size of the organ Nuclear Medicine Part 8. Therapy 12 Factors Affecting Safety in Radionuclide Therapy Safe handling of radionuclides • • • • • • ordering receipt and unpacking storage dispensing internal transports radioactive waste Safe administration • • • Identification pregnancy breastfeeding Nuclear Medicine Patient preparation The radioactive patient and dose constraints The hospitalized patient •instructions to nursing staff •visitors instructions •discharge of the patient •decommissioning of hospital ward •radioactive waste Emergency procedures Part 8. Therapy 13 Ordering, Receipt & Unpacking •The hospital routines for ordering radionuclides should be followed. •When ordering, be sure the delivery service knows where in the hospital to deliver the material. •Make sure that the package is expected and that no unauthorized person will open it upon arrival. •Before unpacking, check the package. In case of damage, contact your RPO. Nuclear Medicine Part 8. Therapy 14 Storage of I-131 •The radionuclide should be stored in a controlled area, according to national regulations and local rules. •The radionuclide should always be stored in a lead container and preferably in a fridge to prevent evaporation •To reach an acceptable external dose rate, a thickness of 1-4 cm lead is generally required. Nuclear Medicine Part 8. Therapy 15 Dispensing • Protective clothing • Lead shields (bench top shield, vial shield, syringe shield) • Keep the vial in the fume hood and on a tray with lips, lined with plastic backed absorbent pads. • Handle the vial with forceps or similar long handled instruments. • Cover the vial with lead after use. • Check the activity • Fill in the necessary records Nuclear Medicine Part 8. Therapy 16 Internal Transport If the administration of radiopharmaceutical to the patient takes place far from the dispensing room, use a transport container with absorbent pads. Make sure that a warning sign is on the container together with patient name, activity and date. Travel by the most direct route avoiding more heavily occupied areas Nuclear Medicine Part 8. Therapy 17 Radioactive Waste Shall be collected, segregated and disposed of according to national regulations and local rules. Nuclear Medicine Part 8. Therapy 18 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 8 Optimization of Protection in Medical Exposure Module 8.2 Administration of Therapy Precautions Before Administration • Be prepared for an emergency situation. • Careful identification of the patient (hospital routines shall be followed). • Questions to the patient: -Pregnant? -Breastfeeding? -Incontinent? -Nausea? -Living conditions? -Type of work? -Public transportation back home? • Verbal and written individual instructions to the patient. Nuclear Medicine Part 8. Therapy 20 Pregnancy (BSS: Interim Edition) “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 3.156) and in the optimization of protection and safety (para. 3.165).” Nuclear Medicine Part 8. Therapy 21 Radioiodine Therapy and Pregnancy Radioiodine easily crosses the placenta and therapeutic doses can pose significant problems for the fetus, particularly permanent hypothyroidism. Nuclear Medicine Part 8. Therapy 22 Radioiodine Therapy As a rule, a pregnant woman should not be treated with a radioactive substance unless the therapy is required to save her life: in that extremely rare event, the potential absorbed dose and risk to the fetus should be estimated and conveyed to the patient and the referring physician. Considerations may include terminating the pregnancy. Nuclear Medicine Part 8. Therapy 23 Radioiodine Therapy In women, thyroid carcinoma comprises over 80% of cancer of the head and neck diagnosed between the ages of 15-45 years. Thyroid cancers are relatively unaggressive compared to most other cancers. As a result both surgical and radio-iodine treatment are often delayed until after pregnancy. In general, if any therapy is to be performed during pregnancy, it will be surgery during the second or third trimester. Nuclear Medicine Part 8. Therapy 24 Inadvertent Administration of Therapy Dose Menstrual history is often not adequate to ensure that a patient is not pregnant. In most developed countries, it is common practice to obtain a pregnancy test prior to highdose 131 I scanning or therapy for women of childbearing age unless there is a clear history of prior tubal ligation or hysterectomy precluding pregnancy. In spite of the above, it still happens that pregnant women are treated, either because of false histories or because the pregnancy is at such an early stage that the pregnancy test is not yet positive. Nuclear Medicine Part 8. Therapy 25 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. Nuclear Medicine Part 8. Therapy 26 Pregnancy after Therapy Radiopharmaceutical All activities up to (MBq) Au-198 colloid 10000 I-131 iodide (thyroid ca) 5000 I-131 iodide (thyrotoxicosis) 800 I-131 MIBG 5000 P-32 phosphate 200 Sr-89 chloride 150 Y-90 colloid (arthritic joints) 400 Y-90 colloid (malignancy) 4000 Nuclear Medicine Part 8. Therapy Avoid pregnancy (months) 2 4 4 4 3 24 0 1 27 Breast Feeding (BSS: Interim Edition) “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 8. Therapy 28 Breast Feeding Nuclear Medicine Part 8. Therapy 29 Patient Information Needed: •Nausea •Living conditions •Type of work •Public transport Nuclear Medicine -intravenous administration to be considered? -number of people in house? -children? -separate room? -working close to other people? -working with children? -pregnant coworkers? -time? Part 8. Therapy 30 Administration of Therapy: Calibration of Sources (BSS) “3.166. In accordance with para. 3.153(d) and (e), the medical physicist shall ensure that: (a) All sources giving rise to medical exposure are calibrated in terms of appropriate quantities using internationally accepted or nationally accepted protocols; 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 8. Therapy 31 Safe Administration • • • • • I-131 should be administered in a controlled area (hot lab or the patient’s hospital bedroom). A plastic bag for contaminated items should be available as well as paper tissues. The patient is asked to sit at a table covered with adsorbent pads and the floor beneath the patient should also be covered by adsorbent pads. If the I-131 is administered in capsules they should be transferred to the patient mouth by tipping from a small shielded (>1 cm Pb) container. I-131 administered in an oral solution (50 ml) should be sucked up through a straw from the shielded vial by the patient. The vial should be flushed with water several times. The patient should drink several glasses of water to clean the mouth. Nuclear Medicine Part 8. Therapy 32 Safe Administration Nuclear Medicine Part 8. Therapy 33 Safe Administration Procedure for intravenous administration: • • • • • Dispense the radionuclide into a shielded syringe Put the radionuclide in an infusion bottle Line the bottle to the patient using an intravenous catheter Keep the patient in bed until the bottle is empty Remove the bottle and the catheter and dispose of them as radioactive waste Nuclear Medicine Part 8. Therapy 34 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 8 Optimization of Protection in Medical Exposure Module 8.3 The Radioactive Patient: Dose Constraints Shall the Patient be Hospitalized? Can the patient leave? Any restrictions? Nuclear Medicine Part 8. Therapy 36 Dose Constraints (BSS: Interim Edition) “3.172. Registrants and licensees shall ensure that relevant dose constraints (para. 3.148(a)(i)) are used in the optimization of protection and safety in any procedure in which an individual acts as a carer or comforter.” Nuclear Medicine Part 8. Therapy 37 Dose Limitation for Comforters and Visitors of Patients ..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 8. Therapy 38 Exposures From Patient Contamination External saliva perspiration breath urine 0.5 0.1 0.06 0.03 mSv/h 1000 MBq I-131 0 Nuclear Medicine 0.5 Part 8. Therapy 1 2m 39 Biodistribution of I-131 (MIRD) Nuclear Medicine Part 8. Therapy 40 Excretion of I-131 Nuclear Medicine Part 8. Therapy 41 Contamination Administered activity: 1000 MBq I-131 Excretion Concentration Saliva <2 MBq/g Perspiration <20 Bq/cm2 Breathing 100 Bq/l Urine < 500 kBq/ml Contamination utensils 2 kBq surfaces 10 Bq/cm2 air 1 Bq/l toilet 2 kBq/cm2 Generally larger than the derived limits for contamination given by ICRP (publ 57) Nuclear Medicine Part 8. Therapy 42 Exposures from Patient 6 μSv /h* GBq , 0 m Sm-153 26 0 3 μSv /h* GBq , 0 m 9 0,5 3μSv/h* GBq 1m Activity concentration in urine: 0.3 MBq/ml*GBq Nuclear Medicine Part 8. Therapy 43 External Exposure from Patient Sm-153 Dose rate at 0.5 m Mean dose rate (Sv/h*GBq) 10 8 6 4 2 0 0 1 2 3 4 5 Time after injection (h) Nuclear Medicine Part 8. Therapy 44 Restrictions Patient with Iodine-131 Activity of I-131 administered (MBq) 30-200 200-400 400-600 Behaviour restriction Period of restrictions (d) Stay at least 1 metre away from all members 5 9 12 of the household except for very brief periods (a few minutes every day) Restrict close contact (“cuddling” with all members of the household to less than 15 minutes per day, and sleep separately from them Sleep separately from “comforters and cares” 600-800 14 15 21 25 27 - - 4 - 8 1 Avoid prolonged close contact (more than 3 hours at <1 metre) with other adults NOTE THAT: The restriction times in the first two rows run concurrently e.g. for 30-200MBq category, a child should only be cuddled for brief periods for 5 days, then cuddling must be restricted to 15 min per day for a further 10 days. The dose constraint for the third row is 5 mSv The fourth row only covers on single event whereas the other categories assume daily contact. Nuclear Medicine Part 8. Therapy 45 Restrictions Patient with Iodine-131 Public travel allowed per day Activity 1:st w 2:nd w (MBq) (h) (h) 200 3,5 24 400 1,5 14 600 1 9 800 0,5 7 Nuclear Medicine Off work (d) 0 3 6 8 Sleep apart from partner pregn. no (d) (d) 15 1 20 8 24 11 26 13 Part 8. Therapy Restricted close contact with children <2 y 2-5 y 5-11 y (d) (d) (d) 15 11 5 21 16 11 25 20 14 27 22 16 46 Therapy Patient The dose to a family member staying at a distance of 0.5 meters from the patient until the radioactivity totally decays (about 10 weeks) is about 1.3 mGy from a hyperthyroid patient and 6.8 mGy from a thyroid cancer patient. These patients must also be careful not to transfer radio-iodine contamination to family members by direct contact or through indirect means Nuclear Medicine Part 8. Therapy 47 Measurements 25 patients who received 220-600 MBq I-131 Husband/wife Children 220-3100 μSv 110- 700 μSv No correlation between administered activity and doses to members of the family. University Hospital, Gothenburg, Sweden Nuclear Medicine Part 8. Therapy 48 Therapy Patient I-131 The patient should be kept at least 2h, and if possible one day in the hospital. In the case of cancer treatment, the patient should generally be hospitalized for several days. In all cases, the dose rate at 1 m from the patient should be down to an acceptable level established by the RPC. Nuclear Medicine Part 8. Therapy 49 Patient Survey Typical Graph of the Exposure Rate at 1 m from the Patient Administered with of 5.5 GBq I-131 14 Exposure Rate (mR/hr) 12 10 8 6 4 2 0 1 2 3 4 5 Days of Isolation Abdalla Al-Haj Nuclear Medicine Part 8. Therapy 50 Guidance level for maximum activity for patients in therapy on discharge from hospital Nuclear Medicine Part 8. Therapy 51 Hospitalization or Not? I-131 1100 MBq stay in hospital stay in hospital or discharged with individual restrictions 600 MBq discharged with individual restrictions 150 MBq discharged, general restrictions Nuclear Medicine Part 8. Therapy 52 Instructions to Out-patients • • • • • • No eating and drinking during the first hour after treatment. During the following two days you should drink more than usual. Use only a WC and flush 2-3 times. Keep the toilet and the floor clean. Wash your hands frequently and take a shower every day. Avoid close contact with members of the family, children and pregnant women according to the time table attached Avoid solid waste Contact the Nuclear medicine department in case of problems or questions. Phone: ………… Nuclear Medicine Part 8. Therapy 53 Avoiding Solid Waste Sensitive detectors at sanitary landfills and solid waste transfer and processing sites have identified contaminated articles from nuclear medicine patients. • Do not use paper plates or disposable cups or flatware. • Use regular dishes, glasses and utensils. Wash them in the sink or dishwasher. • Tissues and paper napkins should go in the toilet, not the garbage. • Food residues should be avoided during the first week (apple cores, chicken bones etc). • Articles contaminated with body fluids that cannot be washed clean or disposed of in the toilet should be stored for decay. Nuclear Medicine Part 8. Therapy 54 Nuclear Medicine Part 8. Therapy 55 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 8 Optimization of Protection in Medical Exposure Module 8.4 The Hospitalized Patient Hospitalized Patient • • • • • • separate room with toilet and shower patient instructions (verbal and written) local rules for nursing the patient local rules for visitors local rules for decontamination local rules for emergency situations Nuclear Medicine Part 8. Therapy 57 Room for Iodine Therapy (controlled area) • only one patient in the room • easily cleanable surfaces and utensils • extra lead shields • door closed • warning sign outside • restrictions for visitors • decontamination equipment Nuclear Medicine Part 8. Therapy 58 Isolation Ward Bed shield is positioned Areas are covered with plastic backed absorbent material. King Faisal Specialist Hospital and Research Center, Riyadh Nuclear Medicine Part 8. Therapy 59 Warning Signs Radiation sign posted on door and on Patient Chart King Faisal Specialist Hospital and Research Center, Riyadh Nuclear Medicine Part 8. Therapy 60 Patient Instructions • • • • Stay in the room. Drink as much as possible. Eat lemon slices. Use only the private toilet and flush 3 times. (Men should sit down to avoid splashing.) • Wash hands well in soapy water after using toilet. • Wear footwear when leaving the bed. • In event of vomiting or incontinence notify the nurse immediately. Nuclear Medicine Part 8. Therapy 61 Instructions to Nursing Staff • Reduce time spent with patient by planning ahead and working efficiently. • Work as far from patient as possible. • Practice preventative measures against contamination. -wear impermeable protection gloves -wear shoe covers -wear a protective gown • Remove protection clothing before leaving the room. Nuclear Medicine Part 8. Therapy 62 Visitors Warning Card The patient you are about to visit has received a therapeutic dose of radioactive iodine. It is in your own best interest to protect yourself as much as possible from receiving more radiation than is necessary. To assist you in meeting that end we offer the following recommendations: • • • • • • • Visitors are discouraged for a 48 hour period after the patient receives the treatment. Pregnant women and children under the age of 18 are not permitted to visit. You should keep your visit short (<30 min). Keep a reasonable distance (e.g. 2 m) away from the patient. Do not kiss the patient. Do not eat, drink or smoke in the patient’s room Do not touch the toilet or sink in the patient’s room If you have any questions, please ask the nursing staff. Nuclear Medicine Part 8. Therapy 63 Discharge of Patient The patient may leave the hospital when his/her radiation level has dropped below the equivalent activity level specified by the Regulatory Authority or the dose constraints specified by the local RPC. E.g. 20 μSv/h which corresponds to an activity of about 500 MBq The patient should be instructed about the general precautions for out-patients Nuclear Medicine Part 8. Therapy 64 Discharge of Patient Typical Graph Showing the Percentage of I-131that is Retained in the Body of a Patient Administered with 5.5 GBq 100 Percentage of I-131 in Body 90 80 70 60 50 40 30 20 10 0 1 2 3 4 5 Day of Isolation Abdalla Al-Haj Nuclear Medicine Part 8. Therapy 65 Discharge of Patient Graph Showing the Number of Patients (5GBq) and the Number of Days of Isolation (Year 2000 Statistics) 160 142 (75%) 140 Number of Patients 120 100 80 60 (16%) 31 40 (5%) (4%) 8 20 10 0 0 1 2 3 4 5 Number of Days of Isolation Abdalla Al-Haj Nuclear Medicine Part 8. Therapy 66 Decontamination The RPO should supervise the removal of contaminated waste, the decontamination of the room and equipment and should make a documented final survey of the room. Monitoring and decontamination must be done prior to entry of nursing and housekeeping staff to prepare the room for the next patient. When survey and decontamination procedures are complete, the RPO will remove the radiation warning sign and notify the nursing and housekeeping staff that the room is now clear for general use. Nuclear Medicine Part 8. Therapy 67 Monitoring Areas suspected to be contaminated are surveyed. Furniture and telephone sets are surveyed. King Faisal Specialist Hospital and Research Center, Riyadh Nuclear Medicine Part 8. Therapy 68 Monitoring Area or item Initial (Bq/cm2) After cleaning (Bq/cm2) Toilet Washroom floor Sink and Faucets Shower Bed Armchair Bedroom floor TV/Telephone Bedside table Doorknobs Lamp switches Nuclear Medicine Derived limit: 3 Bq/cm2 METHODS • wipe testing • direct surveying Part 8. Therapy 69 Ready for a New Patient A “Radiation Safe” sign is posted at the door after decontamination and clearing of room King Faisal Specialist Hospital and Research Center, Riyadh Nuclear Medicine Part 8. Therapy 70 Radioactive Waste • Faeces, urine and other liquids should be disposed of via the toilet. • Contaminated clothing, linen, food items etc which can not go into the toilet should be stored in a separate plastic bag labeled ’RADIOACTIVE’, and should be removed daily to the designated radioactive waste storage facility. • Disposable cutlery and dishes should be used. If not, they should be washed in the patient’s room and reused by the patient. Nuclear Medicine Part 8. Therapy 71 Radioactive Waste All patient radioactive wastes are placed in a plastic bag and the bag is properly tagged. Nuclear Medicine Part 8. Therapy 72 IAEA Training Material on Radiation Protection in Nuclear Medicine Part 8 Optimization of Protection in Medical Exposure Module 8.5 Emergency Procedures: Death of Patient HELP! Nuclear Medicine Part 8. Therapy 74 Safety Assessment Contingency Plan A safety assessment will reveal the possible situations where emergency actions have to be taken: •Loss or damage of radioactive material •Spillage of radioactive material •Fire •Medical emergencies •... A detailed contingency plan covering actions to be taken in any foreseeable accident should be available. Nuclear Medicine Part 8. Therapy 75 Death of Patient In the event of death of a patient who has recently received a therapeutic dose of a radionuclide care has to be taken to ensure that personnel receive as low a dose as possible at all stages prior to the burial or cremation. Activity (MBq) Radionuclide I-131 Y-90 colloid Au-198 colloid P-32 Sr-89 Burial 400 2000 400 2000 2000 Cremation 400 70 100 30 200 (UK) Nuclear Medicine Part 8. Therapy 76 Death of Patient Precautions that should be given are depending on the residual activity and the expert advice provided by the RPO and may involve the following: • preparation for burial or cremation should be controlled by a competent person, • relatives should be prevented from coming into close contact with the body, • people should not be allowed to linger in the presence of the coffin, • all personnel involved in handling the corpse should be instructed by the RPO and monitored if appropriate, • all objects, clothes, documents etc that might have been in contact with the deceased must be tested for contamination, • it may be expedient to wrap the cadaver in waterproof material immediately after death to prevent spread of contaminated body fluids, • embalming of cadavers should, if possible, be avoided, • autopsy of highly radioactive cadavers should be restricted to the absolute minimum Nuclear Medicine Part 8. Therapy 77 Questions? Nuclear Medicine Part 8. Therapy 78 Discussion Discuss the advantages/disadvantages of giving the patient a standard activity of I-131 in a capsule or giving a carefully calculated activity based on a prescribed dose to the thyroid. Nuclear Medicine Part 8. Therapy 79 Discussion 1. Who should prescribe a thyroid treatment with I-131? 2. Who should perform the treatment? Nuclear Medicine Part 8. Therapy 80 Discussion Define some emergency situations or other hazardous events that can occur in an isolation ward and how to handle the situations. Nuclear Medicine Part 8. Therapy 81 Where to Get More Information Other sessions Part 6 Medical exposure Part 5 Occupational exposure Part 4 Design Further readings IAEA, International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources Safety Series No.115, Interim Edition (2011) IPEM, Medical and Dental Guidance Notes. A good practice guide to implement ionising radiation protection legislation in the clinical environment IAEA/WHO Manual on Radiation Protection in Hospitals and General Practice, Volume 4, Nuclear Medicine IAEA, Manual on therapeutic use of iodine-131. Practical Radiation Safety Guide Nuclear Medicine Part 8. Therapy 82