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Quality assurance guidelines for superficial hyperthermia clinical trials : II. Technical requirements for heating devices.

  • Author(s): Dobšíček Trefná, Hana
  • Crezee, Johannes
  • Schmidt, Manfred
  • Marder, Dietmar
  • Lamprecht, Ulf
  • Ehmann, Michael
  • Nadobny, Jacek
  • Hartmann, Josefin
  • Lomax, Nicolleta
  • Abdel-Rahman, Sultan
  • Curto, Sergio
  • Bakker, Akke
  • Hurwitz, Mark D
  • Diederich, Chris J
  • Stauffer, Paul R
  • Van Rhoon, Gerard C
  • et al.
Abstract

Quality assurance (QA) guidelines are essential to provide uniform execution of clinical trials with uniform quality hyperthermia treatments. This document outlines the requirements for appropriate QA of all current superficial heating equipment including electromagnetic (radiative and capacitive), ultrasound, and infrared heating techniques. Detailed instructions are provided how to characterize and document the performance of these hyperthermia applicators in order to apply reproducible hyperthermia treatments of uniform high quality. Earlier documents used specific absorption rate (SAR) to define and characterize applicator performance. In these QA guidelines, temperature rise is the leading parameter for characterization of applicator performance. The intention of this approach is that characterization can be achieved with affordable equipment and easy-to-implement procedures. These characteristics are essential to establish for each individual applicator the specific maximum size and depth of tumors that can be heated adequately. The guidelines in this document are supplemented with a second set of guidelines focusing on the clinical application. Both sets of guidelines were developed by the European Society for Hyperthermic Oncology (ESHO) Technical Committee with participation of senior Society of Thermal Medicine (STM) members and members of the Atzelsberg Circle.

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