Recommended citation
ICRP, 2019. Radiological protection in therapy with radiopharmaceuticals. ICRP Publication 140. Ann. ICRP 48(1).
Authors on behalf of ICRP
Y. Yonekura, S. Mattsson, G. Flux, W.E. Bolch, L.T. Dauer, D.R. Fisher, M. Lassmann, S. Palm, M. Hosono, M. Doruff, C. Divgi, P. Zanzonico
Abstract - Radiopharmaceuticals are increasingly used for the treatment of various cancers with novel radionuclides, compounds, tracer molecules, and administration techniques. The goal of radiation therapy, including therapy with radiopharmaceuticals, is to optimise the relationship between tumour control probability and potential complications in normal organs and tissues. Essential to this optimisation is the ability to quantify the radiation doses delivered to both tumours and normal tissues. This publication provides an overview of therapeutic procedures and a framework for calculating radiation doses for various treatment approaches. In radiopharmaceutical therapy, the absorbed dose to an organ or tissue is governed by radiopharmaceutical uptake, retention in and clearance from the various organs and tissues of the body, together with radionuclide physical half-life. Biokinetic parameters are determined by direct measurements made using techniques that vary in complexity. For treatment planning, absorbed dose calculations are usually performed prior to therapy using a trace-labelled diagnostic administration, or retrospective dosimetry may be performed on the basis of the activity already administered following each therapeutic administration. Uncertainty analyses provide additional information about sources of bias and random variation and their magnitudes; these analyses show the reliability and quality of absorbed dose calculations. Effective dose can provide an approximate measure of lifetime risk of detriment attributable to the stochastic effects of radiation exposure, principally cancer, but effective dose does not predict future cancer incidence for an individual and does not apply to shortterm deterministic effects associated with radiopharmaceutical therapy. Accident prevention in radiation therapy should be an integral part of the design of facilities, equipment, and administration procedures. Minimisation of staff exposures includes consideration of equipment design, proper shielding and handling of sources, and personal protective equipment and tools, as well as education and training to promote awareness and engagement in radiological protection. The decision to hold or release a patient after radiopharmaceutical therapy should account for potential radiation dose to members of the public and carers that may result from residual radioactivity in the patient. In these situations, specific radiological protection guidance should be provided to patients and carers.
© 2019 ICRP. Published by SAGE.
Keywords: Radiopharmaceutical therapy; Radionuclide; Dose estimation; Radiological protection.
Key Points
Treatment with radiopharmaceuticals requires administration protocols that justify and optimise the treatment. Individual absorbed dose estimates should be performed for treatment planning and for post administration verification of doses to tumours and normal tissues.
Special consideration should be given to pregnant women and children exposed to ionising radiation. Pregnancy is usually contraindicated in radiopharmaceutical therapy. Breast feeding should be discontinued in patients receiving radiopharmaceutical therapy.
Radiation sources used in radiopharmaceutical therapy can contribute to exposures to medical personnel and others who may spend time within or adjacent to rooms that contain such sources. Meaningful radiation dose reduction and contamination control can be achieved through the use of appropriate procedures, and facility and room design, including shielding where appropriate, as well as education and training to promote awareness and engagement in radiological protection. Accident prevention and review of safe practices in radiopharmaceutical therapy should be an integral part of the design of facilities, equipment, and administration procedures.
Medical practitioners should provide all necessary medical care consistent with the radiological protection principles of justification and optimisation. Radiological protection actions should not prevent or delay life-saving medical procedures or surgery in the event that they may be required for medical care. Staff should be informed and trained with respect to patient radiation levels.
The decision to hospitalise or release a patient after therapy should be made based on existing guidance and regulations, as well as on the individual patient’s situation, considering factors such as the residual activity in the patient, the patient’s wishes, and family considerations (particularly the presence of children or pregnant family members). Information to guide radiological protection at home should be provided to patients and carers.
Executive Summary
(235) The increasing use of radiopharmaceuticals for cancer therapy promises new treatment options for patients. The challenge for all radiation therapy is to optimise the ability to treat cancer successfully (tumour control probability) against potential adverse effects and normal tissue complications. Radiopharmaceutical therapy provides opportunities to maximise the therapeutic index, a measure of both efficacy and safety.
(236) In radiopharmaceutical therapy, the absorbed dose to an organ or tissue is governed by the individual patient biokinetics (uptake, retention, and clearance), which may vary widely from one patient to another. Measurements of radiopharmaceutical biokinetics provide essential information needed for internal dose assessment.
(237) Due to biokinetic differences, personalised dosimetry must be performed for each patient. In principle, a fully personalised approach based on patient-specific measurements can ensure treatment with an appropriate activity level without exceeding normal organ and tissue toxicity thresholds.
(238) Special consideration should be given to pregnant women. Pregnancy is contraindicated in radiopharmaceutical therapy, unless the therapy is life-saving. Female patients should be advised that breast feeding is also contraindicated after therapeutic administration of radionuclides.
(239) In addition to the patients treated with radiopharmaceutical therapy, the people at risk of exposure include hospital staff, members of the patient’s family (including children), carers, neighbours, and the general public. These risks can be effectively managed and mitigated with well-trained staff, appropriate facilities, and the use of patient-specific radiation safety precaution instructions.
(240) Radiological protection measures to minimise medical staff exposures include use of proper equipment and shielding, safe handling of radioactive sources, use of personal protective equipment and tools, and education and training for commitment to improve awareness and engagement in safety practice. Individual monitoring of the worker doses and extremity doses must be considered during the management of radiopharmaceutical therapy patients, and during preparation and administration of the radiopharmaceuticals.
(241) Medical practitioners should provide all necessary medical care consistent with patient safety and appropriate medical management. Radiological protection considerations should not prevent or delay life-saving operations in the event that surgery is required. Staff should be informed when a patient may present a source of radiation exposure. Training should help the staff to put risk concerns into proper perspective.
(242) The decision to hospitalise or release a patient after therapy should be made on an individual basis, considering factors such as the residual activity in the patient and existing guidance and regulations. Specific radiological protection precautions should be provided to patients and carers.
(243) Prevention of medical errors with radiopharmaceuticals should be an integral part of the design of equipment and premises, and of the working procedures.
ICRP, 2019. Radiological protection in therapy with radiopharmaceuticals. ICRP Publication 140. Ann. ICRP 48(1).
Authors on behalf of ICRP
Y. Yonekura, S. Mattsson, G. Flux, W.E. Bolch, L.T. Dauer, D.R. Fisher, M. Lassmann, S. Palm, M. Hosono, M. Doruff, C. Divgi, P. Zanzonico
Abstract - Radiopharmaceuticals are increasingly used for the treatment of various cancers with novel radionuclides, compounds, tracer molecules, and administration techniques. The goal of radiation therapy, including therapy with radiopharmaceuticals, is to optimise the relationship between tumour control probability and potential complications in normal organs and tissues. Essential to this optimisation is the ability to quantify the radiation doses delivered to both tumours and normal tissues. This publication provides an overview of therapeutic procedures and a framework for calculating radiation doses for various treatment approaches. In radiopharmaceutical therapy, the absorbed dose to an organ or tissue is governed by radiopharmaceutical uptake, retention in and clearance from the various organs and tissues of the body, together with radionuclide physical half-life. Biokinetic parameters are determined by direct measurements made using techniques that vary in complexity. For treatment planning, absorbed dose calculations are usually performed prior to therapy using a trace-labelled diagnostic administration, or retrospective dosimetry may be performed on the basis of the activity already administered following each therapeutic administration. Uncertainty analyses provide additional information about sources of bias and random variation and their magnitudes; these analyses show the reliability and quality of absorbed dose calculations. Effective dose can provide an approximate measure of lifetime risk of detriment attributable to the stochastic effects of radiation exposure, principally cancer, but effective dose does not predict future cancer incidence for an individual and does not apply to shortterm deterministic effects associated with radiopharmaceutical therapy. Accident prevention in radiation therapy should be an integral part of the design of facilities, equipment, and administration procedures. Minimisation of staff exposures includes consideration of equipment design, proper shielding and handling of sources, and personal protective equipment and tools, as well as education and training to promote awareness and engagement in radiological protection. The decision to hold or release a patient after radiopharmaceutical therapy should account for potential radiation dose to members of the public and carers that may result from residual radioactivity in the patient. In these situations, specific radiological protection guidance should be provided to patients and carers.
© 2019 ICRP. Published by SAGE.
Keywords: Radiopharmaceutical therapy; Radionuclide; Dose estimation; Radiological protection.
Key Points
Treatment with radiopharmaceuticals requires administration protocols that justify and optimise the treatment. Individual absorbed dose estimates should be performed for treatment planning and for post administration verification of doses to tumours and normal tissues.
Special consideration should be given to pregnant women and children exposed to ionising radiation. Pregnancy is usually contraindicated in radiopharmaceutical therapy. Breast feeding should be discontinued in patients receiving radiopharmaceutical therapy.
Radiation sources used in radiopharmaceutical therapy can contribute to exposures to medical personnel and others who may spend time within or adjacent to rooms that contain such sources. Meaningful radiation dose reduction and contamination control can be achieved through the use of appropriate procedures, and facility and room design, including shielding where appropriate, as well as education and training to promote awareness and engagement in radiological protection. Accident prevention and review of safe practices in radiopharmaceutical therapy should be an integral part of the design of facilities, equipment, and administration procedures.
Medical practitioners should provide all necessary medical care consistent with the radiological protection principles of justification and optimisation. Radiological protection actions should not prevent or delay life-saving medical procedures or surgery in the event that they may be required for medical care. Staff should be informed and trained with respect to patient radiation levels.
The decision to hospitalise or release a patient after therapy should be made based on existing guidance and regulations, as well as on the individual patient’s situation, considering factors such as the residual activity in the patient, the patient’s wishes, and family considerations (particularly the presence of children or pregnant family members). Information to guide radiological protection at home should be provided to patients and carers.
Executive Summary
(235) The increasing use of radiopharmaceuticals for cancer therapy promises new treatment options for patients. The challenge for all radiation therapy is to optimise the ability to treat cancer successfully (tumour control probability) against potential adverse effects and normal tissue complications. Radiopharmaceutical therapy provides opportunities to maximise the therapeutic index, a measure of both efficacy and safety.
(236) In radiopharmaceutical therapy, the absorbed dose to an organ or tissue is governed by the individual patient biokinetics (uptake, retention, and clearance), which may vary widely from one patient to another. Measurements of radiopharmaceutical biokinetics provide essential information needed for internal dose assessment.
(237) Due to biokinetic differences, personalised dosimetry must be performed for each patient. In principle, a fully personalised approach based on patient-specific measurements can ensure treatment with an appropriate activity level without exceeding normal organ and tissue toxicity thresholds.
(238) Special consideration should be given to pregnant women. Pregnancy is contraindicated in radiopharmaceutical therapy, unless the therapy is life-saving. Female patients should be advised that breast feeding is also contraindicated after therapeutic administration of radionuclides.
(239) In addition to the patients treated with radiopharmaceutical therapy, the people at risk of exposure include hospital staff, members of the patient’s family (including children), carers, neighbours, and the general public. These risks can be effectively managed and mitigated with well-trained staff, appropriate facilities, and the use of patient-specific radiation safety precaution instructions.
(240) Radiological protection measures to minimise medical staff exposures include use of proper equipment and shielding, safe handling of radioactive sources, use of personal protective equipment and tools, and education and training for commitment to improve awareness and engagement in safety practice. Individual monitoring of the worker doses and extremity doses must be considered during the management of radiopharmaceutical therapy patients, and during preparation and administration of the radiopharmaceuticals.
(241) Medical practitioners should provide all necessary medical care consistent with patient safety and appropriate medical management. Radiological protection considerations should not prevent or delay life-saving operations in the event that surgery is required. Staff should be informed when a patient may present a source of radiation exposure. Training should help the staff to put risk concerns into proper perspective.
(242) The decision to hospitalise or release a patient after therapy should be made on an individual basis, considering factors such as the residual activity in the patient and existing guidance and regulations. Specific radiological protection precautions should be provided to patients and carers.
(243) Prevention of medical errors with radiopharmaceuticals should be an integral part of the design of equipment and premises, and of the working procedures.
