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Release Criteria and Other Radiation Safety Considerations for Radionuclide Therapy

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Nuclear Medicine Therapy

Abstract

Historically, nuclear medicine has been largely a diagnostic specialty, utilizing relatively low administered activities to obtain important diagnostic information whose benefits far outweigh the small potential risk associated with the attendant low normal-tissue radiation doses to the patient. Doses and risks to members of the patient’s household and other individuals encountering the patient are, of course, far lower—to the point that medical confinement of and other regulatory restrictions on diagnostic nuclear medicine patients are entirely unnecessary. However, by incorporation of appropriate radionuclides in appropriately large amounts into target tissue-avid radiopharmaceuticals, a sufficiently high radiation dose may be delivered to produce a therapeutic response in tumor or other target tissues. And radionuclide therapy—most notably, radioiodine treatment of thyroid diseases such as hyperthyroidism and differentiated thyroid cancer—has long proven to be effective and safe for patients and for individuals around the patient. With the approval of the Texas State Department of Health, for example, Allen and Zelenski prospectively treated 430 home-bound outpatients over 30 years with 30–400 mCi of iodine-131 and reported that there was no demonstrable health hazard to family members or the general public [1]. Nonetheless, concerns persist regarding stochastic radiogenic risks (i.e., carcinogenesis and germ cell mutagenesis) to individuals incidentally irradiated by radionuclide-treated patients. Such concerns have led governmental authorities worldwide to establish regulatory criteria for the release of radionuclide therapy patients from medical confinement, until 1997 1,110 MBq (30 mCi) of iodine-131 (131I) in the United States but as low as 74 MBq (2 mCi) in some European countries [2–7]. To optimize clinical efficacy, cost-effectiveness, and accessibility to 131I and other radionuclide therapies and their benefits, such regulations must be based on sound dosimetric and radiobiologic principles and available relevant data. In the 1990s, major regulatory changes were implemented in the United States by the Nuclear Regulatory Commission (NRC) regarding release from medical confinement of patients who have received therapeutic amounts of radioactivity [6, 7]. Most notably, release may now be based on the projected effective dose equivalent to individuals exposed to radioactive patients rather than retained activity, thus allowing consideration of patient-specific kinetic and dosimetric data and other patient-specific factors.

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Notes

  1. 1.

     Here and throughout the current chapter, the term, “radiation safety officer (RSO),” refers to the RSO himself and his staff or other designee(s).

  2. 2.

     The terms “dose rate” (in mSv/h or mrem/h) is actually the dose equivalent rate. For x- and γ-rays, the type of radiation to which individuals around a radionuclide therapy patients are potentially exposed, the absorbed dose (rate) and dose-equivalent (rate) as well as the exposure (rate) are very nearly numerically equal and are used interchangeably in the in the current chapter.

  3. 3.

     On behalf of the NCRP, the author of this chapter will provide this EXCEL file upon request.

  4. 4.

     In the case of radioiodine treatment of thyroid cancer, for example, the administered radioiodine is rapidly excreted (with a whole-body biological half-time of only ∼2 days or less). In treating hyperthyroidism, however, 25–50 % of the radioiodine localizes in the thyroid, and that activity is cleared from the gland (and, in turn, the body) much more slowly, with half-times of ∼20 days or longer. Accordingly, the retained activity from the much higher activity (typically greater than 100 mCi) administered to the thyroid cancer patient is rapidly reduced to a lower activity than that retained by the hyperthyroid patient (who typically receive only 10 mCi). Thus, higher dose-rate irradiation of individuals around the patient persists considerably longer in the case of hyperthyroidism than of thyroid cancer, despite the much larger activities used to treat the latter.

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Correspondence to Pat B. Zanzonico Ph.D. .

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Zanzonico, P.B. (2013). Release Criteria and Other Radiation Safety Considerations for Radionuclide Therapy. In: Aktolun, C., Goldsmith, S. (eds) Nuclear Medicine Therapy. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4021-5_22

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