title: Quality assurance guidelines for superficial hyperthermia clinical trials : II. Technical requirements for heating devices.
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.
authors.affiliation: Signals and Systems, Chalmers University of Technology, Gothenburg, Sweden. hanatre@chalmers.se.
authors.forename: Hana
authors.initials: H
authors.lastname: Dobšíček Trefná
authors.affiliation: Radiotherapy, AMC, Amsterdam, The Netherlands.
authors.forename: Johannes
authors.initials: J
authors.lastname: Crezee
authors.affiliation: Radiotherapy Clinics, Universitatsklinikum Erlangen, Erlangen, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Schmidt
authors.affiliation: Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Marder
authors.affiliation: Radiation Oncology, University Hospital Tuebingen, Tuebingen, Germany.
authors.forename: Ulf
authors.initials: U
authors.lastname: Lamprecht
authors.affiliation: Radiation Oncology, University Medical Centre Mannheim, Mannheim, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Ehmann
authors.affiliation: Klinik für Radioonkologie und Strahlentherapie, Campus Virchow Klinikum, Charité Universitatsmedizin Berlin, Berlin, Germany.
authors.forename: Jacek
authors.initials: J
authors.lastname: Nadobny
authors.affiliation: Radiotherapy Clinics, Universitatsklinikum Erlangen, Erlangen, Germany.
authors.forename: Josefin
authors.initials: J
authors.lastname: Hartmann
authors.affiliation: Kantonsspital Aarau, Aarau, Switzerland.
authors.forename: Nicolleta
authors.initials: N
authors.lastname: Lomax
authors.affiliation: Department of Internal Medicine III, Ludwig Maximilians University of Munich, Munich, Germany.
authors.forename: Sultan
authors.initials: S
authors.lastname: Abdel-Rahman
authors.affiliation: Radiation Oncology, Erasmus MC Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.
authors.forename: Sergio
authors.initials: S
authors.lastname: Curto
authors.affiliation: Radiotherapy, AMC, Amsterdam, The Netherlands.
authors.forename: Akke
authors.initials: A
authors.lastname: Bakker
authors.affiliation: Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, USA.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Hurwitz
authors.affiliation: Department of Radiation Oncology, UCSF, San Francisco, CA, USA.
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Diederich
authors.affiliation: Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, USA.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Stauffer
authors.affiliation: Radiation Oncology, Erasmus MC Daniel den Hoed Cancer Center, Rotterdam, The Netherlands.
authors.forename: Gerard C
authors.initials: GC
authors.lastname: Van Rhoon
mesh_terms: D002986:Clinical Trials as Topic / Q000295:instrumentation* / Q000592:standards*; D004867:Equipment Design; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards; D005858:Germany; D006979:Hyperthermia, Induced / Q000295:instrumentation* / Q000592:standards*; D007259:Infrared Rays; D038622:Internationality; D008872:Microwaves; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000592:standards*
keywords: Applicator; Heating criteria; Hyperthermia, superficial; Phantoms; Quality assurance; Water bolus