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SNMMI Press Releases

May 5, 2011

The Case for Maintaining Current Regulations on I-131 Therapy

Reston, Va. – Two articles in the June issue of The Journal of Nuclear Medicine make a case for maintaining current U.S. Nuclear Regulatory Commission (NRC)  regulations on the release of patients who undergo radioactive iodine treatments for thyroid cancer. Currently, the NRC recommends outpatient treatment for patients receiving radioactive iodine after total or near-total thyroidectomy; however, several groups have been urging NRC to mandate overnight hospital stays to protect others from a perceived risk of radiation exposure.

The article, “Delayed Initial Radioactive Iodine Therapy Resulted in Poor Survival in Patients with Metastatic Differentiated Thyroid Carcinoma: A Retrospective Statistical Analysis of 198 Cases,” evaluated the clinical factors that affected the survival of postoperative patients with differentiated thyroid cancer (DTC) in Japan. According to Tatsuya Higashi, MD, PhD, this is the first report that shows the prognostic value of early performance of radioactive iodine therapy. 

Researchers found that the risk of death for patients who received radioactive iodine treatment more than 180 days after a total thyroidectomy was 4.22 times higher than for those treated within the initial 180 days. Several reasons were cited as causing delays in treatment time in Japan, including strict regulation of radioactive materials, a long waiting list for admission to the radioactive iodine therapy ward and delayed referral by the surgeons who performed the total thyroidectomy.

In a related article, “The Real Cost of Theoretic Risk Avoidance: The Need to Challenge Unsubstantiated Concerns About 131I Therapy,” Stanley J. Goldsmith, MD, cites the Japan study as a reason to maintain current NRC regulations. If the NRC were to require overnight stays, he reasons, a backlog could result, causing delays in treatment of patients.

He further addresses the concerns of individuals and political representatives seeking to reverse or revise the current NRC guidelines on patient release after 131I therapy, stating that in spite of many epidemiologic studies completed on the issue, low-dose radiation has never been established to be a causal factor in the development of malignancy. “In no instance,” he writes, “is an individual likely to receive radiation exposure in excess of a level deemed exceedingly safe.”

The Society of Nuclear Medicine issued a joint statement with the American Thyroid Association, The Endocrine Society and the American Association of Clinical Endocrinologists explaining that based on existing scientific evidence, the current 131I regulations are safe for patients, their families and the public when radiation safety instructions are followed. However, SNM supports reexamination of this issue if new data emerge that support concerns about public safety.

Authors of the article “Delayed Initial Radioactive Iodine Therapy Resulted in Poor Survival in Patients with Metastatic Differentiated Thyroid Carcinoma: A Retrospective Statistical Analysis of 198 Cases” include: Tatsuya Higashi, Shiga Medical Center Research Institute, Moriyama City, Shiga, Japan and Department of Diagnostic Imaging and Nuclear Medicine, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan; Ryuichi Nishii, Shiga Medical Center Research Institute, Moriyama City, Shiga, Japan; Yuji Nakamoto, Koichi Ishizu, Shigeto Kawase and Kaori Togashi, Department of Diagnostic Imaging and Nuclear Medicine, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan; Shigeki Yamada, Department of Neurosurgery, Shiga Medical Center, Moriyama City, Shiga, Japan and Department of Neurosurgery, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan; Satoshi Itasaka and Masahiro Hiraoka, Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan; Takashi Misaki, Department of Diagnostic Imaging and Nuclear Medicine, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan, and Tenri Hospital Radioisotope Center, Tenri, Nara, Japan; and Junji Konishi, Department of Diagnostic Imaging and Nuclear Medicine, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan and Sugita Genpaku Memorial Obama Municipal Hospital, Obama, Fukui, Japan.

Stanley J. Goldsmith, New York Presbyterian Hospital and Weill Medical College of Cornell University, New York, New York, is the author of “The Real Cost of Theoretic Risk Avoidance: The Need to Challenge Unsubstantiated Concerns about 131I Therapy.”

Please visit the SNM Newsroom to view the PDF of the study, including images. To schedule an interview with the researchers, please contact Susan Martonik at (703) 652-6773 or smartonik@snm.org.Current and past issues of The Journal of Nuclear Medicinecan be found online at http://jnm.snmjournals.org.

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About SNM—Advancing Molecular Imaging and Therapy

SNM is an international scientific and medical organization dedicated to raising public awareness about what molecular imaging is and how it can help provide patients with the best health care possible. SNM members specialize in molecular imaging, a vital element of today’s medical practice that adds an additional dimension to diagnosis, changing the way common and devastating diseases are understood and treated.

SNM’s more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit http://www.snm.org.

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