Journal of Nuclear Medicine, published on July 11, 2012 as doi:10.2967/jnumed.112.105148 The SNM Practice Guideline for Therapy of Thyroid Disease with 131I 3.0* Edward B. Silberstein1 (Chair), Abass Alavi2, Helena R. Balon3,SusanE.M.Clarke4, Chaitanya Divgi5,MichaelJ.Gelfand6, Stanley J. Goldsmith7, Hossein Jadvar8, Carol S. Marcus9, William H. Martin10, J. Anthony Parker11, Henry D. Royal12, Salil D. Sarkar13, Michael Stabin14, and Alan D. Waxman15 1UC Health University Hospital, Cincinnati, Ohio; 2Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; 3Beaumont Health System, Royal Oak, Michigan; 4Guy’s Hospital, London, United Kingdom; 5Columbia University Medical Center, New York, New York; 6Cincinnati Children’s Medical Center, Cincinnati, Ohio; 7New York–Presbyterian/Weill Cornell Medical Center, New York, New York; 8University of Southern California, Los Angeles, California; 9University of California at Los Angeles, Los Angeles, California; 10Vanderbilt University Medical Center, Nashville, Tennessee; 11Beth Israel Deaconess Medical Center, Boston, Massachusetts; 12Mallinckrodt Institute of Radiology, St. Louis, Missouri; 13Jacobi Medical Center, Bronx, New York; 14Vanderbilt University, Nashville, Tennessee; and 15Cedars-Sinai Medical Center, Los Angeles, California 3. Information required by the physician performing the procedure: blood tests . .10 INDEX 4. Selection of activity. ...............11 Preamble ................................. 1 5. Therapeutic procedure for administration I. Introduction: patient management, licensure. .... 2 of 131I.........................12 II. Goals................................ 2 6. Follow-up. ......................12 III. Definitions: risk levels.................... 2 C. Radiation safety issues, patient discharge, IV. Common clinical indications ............... 3 home instructions ...................12 V. Qualifications and responsibilities of personnel D. Interactions of 131I with other forms of (in the United States). .................... 3 diagnosis or treatment ................14 VI. Procedure/specifications of the examination ..... 4 E. Radiopharmaceuticals. ................15 A. Therapy of Graves disease, toxic nodules, F. Issues requiring further clarification. ......15 and nontoxic nodular goiter ............ 4 VII. Documentation/reporting ..................15 1. Goals. ......................... 4 VIII. Equipment specification...................16 2. Patient preparation: thionamides, consent IX. Quality control and improvement ............16 form, rhTSH use.................. 4 X. Safety, infection control, and patient 3. Information required by the physician education concerns......................16 performing the procedure; scintigraphy; XI. Radiation dosimetry. .....................16 pregnancy and lactation ............. 5 XII. Acknowledgments.......................16 4. Selection of administered activity ...... 6 XIII. References ............................16 5. Therapeutic procedure for administration XIV. Approval .............................19 of 131I......................... 6 6. Follow-up. ...................... 6 B. 131I therapy of thyroid cancer to ablate post- PREAMBLE thyroidectomy remnants and destroy residual The Society of Nuclear Medicine (SNM) is an interna- or recurrent tumor................... 7 tional scientific and professional organization founded in 1. Indications for treatment with 131I: 1954 to promote the science, technology, and practical relationship to staging .............. 7 application of nuclear medicine. Its 16,000 members are 2. Patient preparation and information physicians, technologists, and scientists specializing in the the patient needs: diet, TSH level, research and practice of nuclear medicine. In addition to informed consent, side effects. ........ 8 publishing journals, newsletters, and books, the SNM also sponsors international meetings and workshops designed to Received Feb. 27, 2012; accepted Feb. 27, 2012. For correspondence or reprints contact Edward B. Silberstein, Department increase the competencies of nuclear medicine practitioners of Nuclear Medicine, University of Cincinnati Medical Center, 234 Goodman and to promote new advances in the science of nuclear St., Room G026, Mont Reid Pavilion, Cincinnati, OH 45219. E-mail: [email protected] medicine. *NOTE: YOU CAN ACCESS THIS GUIDELINE THROUGH THE SNM The SNM will periodically define new guidelines for WEBSITE (http://www.snm.org/guidelines). COPYRIGHT ª 2012 by the Society of Nuclear Medicine, Inc. nuclear medicine practice to help advance the science of DOI: 10.2967/jnumed.112.105148 nuclear medicine and to improve the quality of service to THERAPY OF THYROID DISEASE WITH 131I • Silberstein et al. 1 jnm105148-sn n 7/11/12 Copyright 2012 by Society of Nuclear Medicine. patients throughout the United States. Existing practice with other physicians involved in the management of the guidelines will be reviewed for revision or renewal, as patient’s condition. The treating physician should either see appropriate, on their fifth anniversary or sooner, if indicated. patients in consultation with the physician assuming overall Each practice guideline, representing a policy statement management of the patient’s condition or be prepared by the SNM, has undergone a thorough consensus process to assume that role. In the United States, the treating physi- in which it has been subjected to extensive review, cian should be board-certified in nuclear medicine or be able requiring the approval of the Committee on Guidelines to document equivalent training, competency, and experience and SNM Board of Directors. The SNM recognizes that the in the safe use and administration of therapeutic 131I. safe and effective use of diagnostic nuclear medicine Licensure to possess 131I and regulations regarding the imaging requires specific training, skills, and techniques, release of patients treated with radioiodine vary from juris- as described in each document. Reproduction or modifica- diction to jurisdiction. Physicians engaged in therapy with tion of the published practice guideline by those entities not 131I must be knowledgeable about, and in compliance with, providing these services is not authorized. all applicable laws and regulations. The facility in which These guidelines are an educational tool designed to treatment is performed must have appropriate personnel, assist practitioners in providing appropriate care for radiation safety equipment, and procedures available for patients. They are not inflexible rules or requirements of waste handling and disposal, monitoring personnel for ac- practice and are not intended, nor should they be used, to cidental contamination, and controlling spread of 131Ito establish a legal standard of care. For these reasons and conform to state and federal regulations. All physicians those set forth below, the SNM cautions against the use of engaged in therapy have a duty to ensure that their knowl- these guidelines in litigation in which the clinical decisions edge and competencies are up to date. of a practitioner are called into question. The ultimate judgment regarding the propriety of any II. GOALS specific procedure or course of action must be made by the The purpose of this guideline is to assist trained physician or medical physicist in light of all the circum- practitioners in evaluating patients for therapy with 131I stances presented. Thus, there is no implication that an (sodium iodide) for benign or malignant diseases of the approach differing from the guidelines, standing alone, was thyroid gland, performing this treatment in a safe and ap- below the standard of care. To the contrary, a conscientious propriate manner, understanding and evaluating the se- practitioner may responsibly adopt a course of action quelae of therapy, and reporting the results of therapy. different from that set forth in the guidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations III. DEFINITIONS of available resources, or advances in knowledge or See also the SNM Guideline for General Imaging. technology subsequent to publication of the guidelines. 131Iisab-emitting radionuclide with a physical half-life The practice of medicine involves not only the science, but of 8.1 d; a principal g-ray of 364 keV; and a principal also the art, of dealing with the prevention, diagnosis, b-particle with a maximum energy of 0.61 MeV, an average alleviation, and treatment of disease. The variety and energy of 0.192 MeV, and a mean range in tissue of 0.4 mm complexity of human conditions make it impossible to always (1,2). Therapy means the oral administration of 131I as so- reach the most appropriate diagnosis or to predict with dium iodide to treat papillary and follicular thyroid cancer, certainty a particular response to treatment. Therefore, it hyperthyroidism, or nontoxic nodular goiter, in contrast to should be recognized that adherence to these guidelines will the diagnostic use of radioiodine to detect functioning thy- not ensure an accurate diagnosis or a successful outcome. All roid tissue. Benign diseases include Graves disease (toxic that should be expected is that the practitioner will follow diffuse goiter) and toxic or nontoxic nodular goiter. Ma- a reasonable course of action based on current knowledge, lignant diseases in this guideline indicate papillary and available resources, and the needs of the patient to deliver follicular types of thyroid