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

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.

Biophysical and photobiological basics of water-filtered infrared-A hyperthermia of superficial tumors

“…Vertical temperature profiles exhibited a temperature rise of 9.6 K at 1 cm depth within 6 min as using an irradiance of only 92 mW/cm 2 ( Figure 13, curve B). Choosing the recommended irradiance of 200 mW/cm 2 , the respective temperature rise is 20.8 K, thus exceeding the minimum temperature increase (as required by ESHO [22]) by a factor 2.2 ( Figure 13, curve A). Under these conditions, the thermal effective penetration depth (TEPD) as defined by ESHO [22] was determined as 9.0 mm.…”

“…This is shown in Figure 10(B). Maximum skin surface temperature of all patients increased up to approximately 43 C within less than 5 À 6 min after starting exposure as required by the ESHO guidelines [22]. Moreover, maximum skin surface temperatures were maintained between 42.5 and 43 C during the whole treatment session according to the therapeutic schedule and in order to prevent heat pain and burns [47,48].…”

“…Due to the above mentioned preclinical and clinical data, wIRA has been listed as an appropriate heating technique in the new ESHO quality assurance guidelines for superficial hyperthermia trials [21,22]. In order to assess the special features and the potential of thermographically controlled wIRA as well as the differences to currently used radio-and microwave heating techniques, detailed and updated biophysical and photobiological background information concerning wIRA (together with possible limitations and treatment options beyond breast cancer recurrences) will be presented in this article.…”

Hyperthermia and Radiotherapy Combination for Locoregional Recurrences of Breast Cancer: A Review

“…It can be performed by temperature probes or noninvasive methods. Guidelines to improve quality assurance problems have been recently outlined by Trefna et al [43].…”

Hyperthermia treatment planning guided applicator selection for sub-superficial head and neck tumors heating

“…It is commonly accepted that hyperthermia treatment quality is positively correlated with improved tumour control [2,5]. Hence, during the last decades ample research has been devoted in developing hyperthermia systems for superficial or deep heating that provide the ability of a flexible and adaptive optimisation of the delivered thermal dose for a specific tumour site [6][7][8]. At our institute, superficial hyperthermia is administered at 434 MHz using incoherent planar applicators, i.e.…”