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Strahlentherapie und Onkologie
Published in: Strahlentherapie und Onkologie 5/2017

Open Access 01-05-2017 | Review Article

Quality assurance guidelines for superficial hyperthermia clinical trials

II. Technical requirements for heating devices

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

Published in: Strahlentherapie und Onkologie | Issue 5/2017

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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.
Appendix
Available only for authorised users
Footnotes
1
This range includes room temperature as required for QA, in addition to the 30–45 °C range typical for clinical treatments.
 
2
The efficiency of the superficial hyperthermia system is obtained by calculating the ratio of the EM power absorbed in the phantom to the net power input to the applicator (forward minus reflected power measured at the output of the amplifier minus cable losses between amplifier and applicator). The EM power absorbed in the phantom is measured using the calorimetric method: a well-insulated and well-stirred liquid muscle-tissue equivalent phantom is heated by the applicator for 10 min with a high EM-power input. The homogeneous temperature increase of the liquid muscle-tissue equivalent phantom is measured and total absorbed energy calculated from Pa = ρ∗cp∗V∗dT/dt [J/s], in which Pa is absorbed power, ρ is the density, and cp is the specific heat capacity of the liquid muscle-tissue equivalent phantom material, V is the volume, dT the temperature increase, dt is the duration of heating.
 
3
TX 150 & TX 151 (Oil Center Research International, L.L.C., Lafayette, LA 70503).
* In original work [70], highly toxic NaN3 was used as preservative. Other, less toxic preservatives were given with the mass equivalent quantities of NaCl, to compensate the conductivity decrease. Here the recipe is adopted for use with formaldehyde 8%. The phantom can be, however, prepared even without this preservative. In such a case, an equivalent amount of water should be used.
 
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Metadata
Title
Quality assurance guidelines for superficial hyperthermia clinical trials
II. Technical requirements for heating devices
Authors
Hana Dobšíček Trefná
Johannes Crezee
Manfred Schmidt
Dietmar Marder
Ulf Lamprecht
Michael Ehmann
Jacek Nadobny
Josefin Hartmann
Nicolleta Lomax
Sultan Abdel-Rahman
Sergio Curto
Akke Bakker
Mark D. Hurwitz
Chris J. Diederich
Paul R. Stauffer
Gerard C. Van Rhoon
Publication date
01-05-2017
Publisher
Springer Berlin Heidelberg
Published in
Strahlentherapie und Onkologie / Issue 5/2017
Print ISSN: 0179-7158
Electronic ISSN: 1439-099X
DOI
https://doi.org/10.1007/s00066-017-1106-0

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