International Atomic Energy Agency - Production, Quality Control and Clinical Applications of Radiosynovectomy Agents

Therapeutic radiopharmaceuticals play a major role in todays nuclear medicine, especially in the treatment of cancer. They have long been applied in radiation synovectomy, or, more briefly, radiosynovectomy (RSV) . In recent decades, the production and quality control of radiopharmaceuticals for use in RSV has moved from simple P colloids to recently developed matrixes labelled with short and medium range beta emitters. RSV is a well established technique with growing applications worldwide. However, the lack of generic and peer reviewed production, quality control and clinical application guidelines and recommendations is a major concern for their application in human patients.

Given both the IAEAs global efforts in supporting Member States in the application of nuclear techniques in radiopharmacy and health and several requests from Member States as well as professional societies in recent years, the need for an IAEA technical publication on the subject became apparent. Currently, there is a lack of international standardized regulations for RSV production and clinical use. This publication is intended for professionals in the field. It outlines ideal quality control and quality assurance procedures in the production of several radiopharmaceuticals for performing RSV, as well as the standard operating procedures needed to achieve successful therapeutic effec ts in patients.

This publication is the outcome of the continuous efforts of an international expert team that was in the field between 2016 and 2018; the IAEA wishes to thank the experts for their valuable work and scientific contribution, especially A. Dash (India) and J. Farahati (Germany). Special thanks to J.S. Vera Araujo from the Division of Physical and Chemical Sciences for her support in revising and editing. The IAEA officers responsible for this publication were A.R. Jalilian and F. Giammarile of the Division of Physical and Chem ical Sciences.

EDITORIAL NOTE

Guidance provided here, describing good practices, represents expert opinion but does not constitute recommendations made on the basis of a consensus of Member States.

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The authoritative version of this publication is the hard copy issued at the same time and available as pdf on www.iaea.or g/p ublications . To create this version for e-readers, certain changes have been made, including a the movement of some figu res and tables.