Universität zu Köln

Konijnenberg, Mark, Herrmann, Ken, Kobe, Carsten, Verburg, Frederik, Hindorf, Cecilia, Hustinx, Roland and Lassmann, Michael . EANM position paper on article 56 of the Council Directive 2013/59/Euratom (basic safety standards) for nuclear medicine therapy. Eur. J. Nucl. Med. Mol. Imaging. NEW YORK: SPRINGER. ISSN 1619-7089

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Abstract

Executive Summary The EC Directive 2013/59/Euratom states in article 56 that exposures of target volumes in nuclear medicine treatments shall be individually planned and their delivery appropriately verified. The Directive also mentions that medical physics experts should always be appropriately involved in those treatments. Although it is obvious that, in nuclear medicine practice, every nuclear medicine physician and physicist should follow national rules and legislation, the EANM considered it necessary to provide guidance on how to interpret the Directive statements for nuclear medicine treatments. For this purpose, the EANM proposes to distinguish three levels in compliance to the optimization principle in the directive, inspired by the indication of levels in prescribing, recording and reporting of absorbed doses after radiotherapy defined by the International Commission on Radiation Units and Measurements (ICRU): Most nuclear medicine treatments currently applied in Europe are standardized. The minimum requirement for those treatments is ICRU level 1 (activity-based prescription and patient-averaged dosimetry), which is defined by administering the activity within 10% of the intended activity, typically according to the package insert or to the respective EANM guidelines, followed by verification of the therapy delivery, if applicable. Non-standardized treatments are essentially those in developmental phase or approved radiopharmaceuticals being used off-label with significantly (> 25% more than in the label) higher activities. These treatments should comply with ICRU level 2 (activity-based prescription and patient-specific dosimetry), which implies recording and reporting of the absorbed dose to organs at risk and optionally the absorbed dose to treatment regions. The EANM strongly encourages to foster research that eventually leads to treatment planning according to ICRU level 3 (dosimetry-guided patient-specific prescription and verification), whenever possible and relevant. Evidence for superiority of therapy prescription on basis of patient-specific dosimetry has not been obtained. However, the authors believe that a better understanding of therapy dosimetry, i.e. how much and where the energy is delivered, and radiobiology, i.e. radiation-related processes in tissues, are keys to the long-term improvement of our treatments.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Konijnenberg, Mark UNSPECIFIED UNSPECIFIED UNSPECIFIED Herrmann, Ken UNSPECIFIED UNSPECIFIED UNSPECIFIED Kobe, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Verburg, Frederik UNSPECIFIED UNSPECIFIED UNSPECIFIED Hindorf, Cecilia UNSPECIFIED UNSPECIFIED UNSPECIFIED Hustinx, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Lassmann, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-314868
DOI:	10.1007/s00259-020-05038-9
Journal or Publication Title:	Eur. J. Nucl. Med. Mol. Imaging
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1619-7089
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DOSIMETRY-COMMITTEE SERIES; RADIOIODINE THERAPY; PROCEDURE GUIDELINE; NO. 20; MIRD; SPECT; GUIDANCE; CANCER Multiple languages Radiology, Nuclear Medicine & Medical Imaging Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/31486