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Trefná HD, Crezee H, Schmidt M, et al. Quality assurance guidelines for superficial hyperthermia clinical trials: I. Clinical requirements. Int J Hyperthermia. 2017;33(4):471-482doi: 10.1080/02656736.2016.1277791.
Trefná, H. D., Crezee, H., Schmidt, M., Marder, D., Lamprecht, U., Ehmann, M., Hartmann, J., Nadobny, J., Gellermann, J., van Holthe, N., Ghadjar, P., Lomax, N., Abdel-Rahman, S., Bert, C., Bakker, A., Hurwitz, M. D., Diederich, C. J., Stauffer, P. R., & van Rhoon, G. C. (2017). Quality assurance guidelines for superficial hyperthermia clinical trials: I. Clinical requirements. International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group, 33(4), 471-482. https://doi.org/10.1080/02656736.2016.1277791
Trefná, Hana Dobšíček, et al. "Quality assurance guidelines for superficial hyperthermia clinical trials: I. Clinical requirements." International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group vol. 33,4 (2017): 471-482. doi: https://doi.org/10.1080/02656736.2016.1277791
Trefná HD, Crezee H, Schmidt M, Marder D, Lamprecht U, Ehmann M, Hartmann J, Nadobny J, Gellermann J, van Holthe N, Ghadjar P, Lomax N, Abdel-Rahman S, Bert C, Bakker A, Hurwitz MD, Diederich CJ, Stauffer PR, van Rhoon GC. Quality assurance guidelines for superficial hyperthermia clinical trials: I. Clinical requirements. Int J Hyperthermia. 2017 Jun;33(4):471-482. doi: 10.1080/02656736.2016.1277791. Epub 2017 Jan 31. PMID: 28049386.
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Int J Hyperthermia. 2017 Jun;33(4):471-482. doi: 10.1080/02656736.2016.1277791. Epub 2017 Jan 31.

Quality assurance guidelines for superficial hyperthermia clinical trials: I. Clinical requirements.

International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group

Hana Dobšíček Trefná, Hans Crezee, Manfred Schmidt, Dietmar Marder, Ulf Lamprecht, Michael Ehmann, Josefin Hartmann, Jacek Nadobny, Johanna Gellermann, Netteke van Holthe, Pirus Ghadjar, Nicoletta Lomax, Sultan Abdel-Rahman, Christoph Bert, Akke Bakker, Mark D Hurwitz, Chris J Diederich, Paul R Stauffer, Gerard C van Rhoon

Affiliations

  1. a Signals and Systems , Chalmers University of Technology , Göteborg , Sweden.
  2. b Radiotherapy , AMC , Amsterdam , The Netherlands.
  3. c Radiotherapy Clinics, Universitatsklinikum Erlangen , Erlangen , Germany.
  4. d Kantonsspital Aarau , Aarau , Switzerland.
  5. e Radiation Oncology , University Hospital Tuebingen , Tuebingen , Germany.
  6. f Radiation Oncology , University Medical Centre Mannheim , Mannheim , Germany.
  7. g Klinik für Radioonkologie und Strahlentherapie , Campus Virchow Klinikum, Charite Universitatsmedizin Berlin , Berlin , Germany.
  8. h Praxis/Zentrum für Strahlentherapie und Radioonkologie , Berlin , Germany.
  9. i Radiation Oncology , Erasmus MC Daniel den Hoed Cancer Center , Rotterdam , The Netherlands.
  10. j Department of Internal Medicine III , Ludwig Maximilians University of Munich , Munich , Germany.
  11. k Department of Biophysics , GSI - Helmholtz Centre for Heavy Ion Research , Darmstadt , Germany.
  12. l Department of Radiation Oncology , Thomas Jefferson University , Philadelphia , PA , USA.
  13. m Department of Radiation Oncology , UCSF , San Francisco , CA , USA.

PMID: 28049386 DOI: 10.1080/02656736.2016.1277791

Abstract

Quality assurance guidelines are essential to provide uniform execution of clinical trials and treatment in the application of hyperthermia. This document provides definitions for a good hyperthermia treatment and identifies the clinical conditions where a certain hyperthermia system can or cannot adequately heat the tumour volume. It also provides brief description of the characteristics and performance of the current electromagnetic (radiative and capacitive), ultrasound and infra-red heating techniques. This information helps to select the appropriate heating technique for the specific tumour location and size, and appropriate settings of the water bolus and thermometry. Finally, requirements of staff training and documentation are provided. The guidelines in this document focus on the clinical application and are complemented with a second, more technical quality assurance document providing instructions and procedure to determine essential parameters that describe heating properties of the applicator for superficial hyperthermia. Both sets of guidelines were developed by the ESHO Technical Committee with participation of senior STM members and members of the Atzelsberg Circle.

Keywords: Quality assurance; clinical; hyperthermia; superficial

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