From fixed activities to personalized treatments in radionuclide therapy: lost in translation?
Abstract
We read with interest the letter by Giammarile et al. [1] addressing our editorial in which we proposed that the European Medicines Agency should allow the option of a dosimetry-based approach to the treatment of cancer with radionuclide therapy [2]. Our editorial was intended to draw attention to the potential legal issues of recommending an approach to treatment that could contravene the European Council Directive 2013/59 [3] and national legislation, as the directive (article 56) states that "For all medical exposure of patients for radiotherapeutic1 purposes, exposures of target volumes shall be individually planned and their delivery appropriately verified.". This directive is intended to "lay down basic safety standards for the protection of dangers arising from exposure to ionizing radiation" and emphasizes the need for 'justification' and 'optimization' of intentional radiation exposures of patients. [.]
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