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INT. J .

HYPERTHERMIA,

1989, VOL. 5,

NO. 4,

421-428

Quality assurance guidelines for ESHO protocols


J. W. HAND?, J. J. W. LAGENDUKS, J. BACH ANDERSENS and J. C. BOLOMEYI tMRC Cyclotron Unit, Hammersmith Hospital, Du Cane Road, London W12 OHS, UK. $Department of Radiotherapy, University Hospital, 3511 GV Utrecht, The Netherlands. $Instituteof Electronic Systems, Aalborg University, DK 9OOO Aalborg, Denmark. YEcole Superieure dElectricite, 9 1190 Gif-sur-Yvette, France.
(Received 8th December 1988; accepted 14th December 1988)
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1. Introduction The following quality assurance guidelines are intended for hyperthermia treatments given as part of ESHO clinical protocols 1-85 (Hyperthermia as an adjunct to radiotherapy in the treatment of locally advanced breast carcinoma), 2-85 (Hyperthermia as an adjunct to radiotherapy in the treatment of advanced neck nodes) and 3-85 (Hyperthermia as an adjunct to radiotherapy in the treatment of malignant melanoma) (ESHO 1986). They have been prepared specifically for external electromagnetic heating techniques. Additional guidelines for ultrasound-induced hyperthermia and interstitial hyperthermia will be prepared in due course. Throughout the guidelines use of the word must implies that compliance with a procedure is mandatory. Use of the word should implies that compliance with a procedure is in line with good practice.

2. Treatment planning 2.1. Routine treatment planning for clinical treatments is not yet available (see 9.1).
2.2. The choice of heating system must be based on practical experience. Factors which must be taken into account include the location, depth and area of the tumour. 2.3. The system chosen must be capable of heating the whole tumour volume. The effective field size (see 6.1) of an applicator or array of applicators must cover the surface dimensions of the tumour. The applicator with the largest practical field size should be used (see 9.2). 2.4. The use of 2450 MHz systems must be restricted to treatment of surface tumours less than 1 cm deep. 2.5. The tumour volume should be heated in a single session. 2.6. As many temperature sensors as possible should be used during treatments. Multisensor probes should be used whenever possible to minimize the number of implanted probes. If probes with single sensors are used then a thermal mapping (pull-back) technique should be used when possible. X-ray or ultrasound diagnostic techniques should be used to locate the position of sensors. Care should be taken to monitor temperatures in high risk areas such as scar tissue. The absolute minimum number of temperature sensors which must be employed during a treatment is protocol-specific. For protocol 1-85 (breast carcinoma) at least three sensors
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must be implanted in the tumour within 1 cm of the periphery. Of these, one must be at depth, e.g. location 1 in figure 1, and two at diametrically opposed locations representative of the lateral dimensions of the tumour, e.g. locations 2 and 3 or 2' and 3' in figure 1. In addition there must be at least one sensor on the skin. For protocol 2-85 (neck nodes) at least one multi-sensor probe with a minimum of three sensors must be implanted in the tumour. At least two of the three sensors must be located in peripheral regions of the tumour (figure 2). In addition, there must be at least one sensor on the skin. If a multi-sensor probe is not available thenapull-backtechnique using a single sensor probe must be employed. For protocol 3-85 (melanoma) at least two sensors must be implanted in tumours with area less than or equal to 16 cm2. In addition, there must be at least one sensor on the skin. If larger tumours are encountered then the number of implanted sensors must be increased by at least one for each additional 16 cm2 of area. Implanted sensors should be located in peripheral regions of the tumour (see 9.2). 2.7. The duration of each treatment should be 60 minutes. This period begins either 10 minutes after commencement of heating (the overall duration is then 70 minutes) or for the time at which all sensors located within the tumour record 43"C,should this occur within 10 minutes of the commencement of heating.

Figure 1. Locations of the minimum number of temperature sensors for treatment of breast carcinoma.

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Figure 2. Locations of the minimum number of temperature sensors for treatment of neck nodes.

If any break occurs during a treatment, the period during which the power is turned off should be measured and added to the overall treatment time to a maximum of 20 minutes (i.e. the maximum time allowed for treatment is 90 minutes). 2.8. During the initial phase of each treatment, the rate of increase of temperature should be approximately 1C per minute. 2.9. Upon termination of heating, temperature at all sensors must be measured and recorded for a further period of 2 minutes. 2.10. A photograph of the clinical set-up should be taken for each treatment.

3. Reporting a summary of the treatment


It is recommended that, in addition to details of the radiation therapy and other clinical information, the following details be recorded on the treatment form to provide a summary of the treatment. 3.1. There must be a record of the applicator or array of applicators used in each treatment. 3.2. There must be a record of the thermometry system(s) used in each treatment. 3.3. There must be a diagram showing the relative positions of tumour, applicator and temperature sensors. 3.4. The temperature at the location of each sensor must be recorded at 5 minute intervals throughout the treatment. These data provide a summary of the temperaturehne record and as such are a subset of the complete record (see 8.3). 3.5. Any break occurring during a treatment must be recorded.

424 J . W.Hand et al. 3.6. The occurrence and nature of any discomfort or pain suffered by a patient during
any treatment must be recorded.

3.7. If a treatment is terminated prematurely then the reason for failure must be recorded. Inclusion of a list of common causes of failure on the treatment form will facilitate this. 3.8. When the concept of thermal isoeffect dose (see 9.6)is used both the minimum and maximum doses monitored within the tumour together with the maximum dose monitored in normal tissue should be recorded. Thermal isoeffect dose must be restricted to individual treatments, i.e. doses recorded in separate treatments must not be added. The recording of thermal isoeffect doses must not be considered as an alternative to recording temperatures.
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3.9. The power delivered by the applicator (see 6.8)should be recorded at 5 minute intervals throughout the treatment.
4. Reporting technical characteristics of equipment The following technical details of any hyperthermia equipment used in treatments must be recorded on an appropriate form. Thermometry: type of thermometer, type and number of probes, number of sensors . per probe (see 5 . 3 , accuracy and stability of thermometer (see 5 1 and 5.2),details of calibration procedure (see 5.3 and 5.4). Applicators: type and operating frequency, the number of elements in a multi-element array applicator, overall dimensions, type of bolus used, dimensions of bolus, effective field size and penetration depth (see 6.1 to 6.6).
5. Requirements and characterization of thermometers 5.1. The accuracy of any thermometer must be 0.2"C or better within the range

37-46C.
5.2. The stability of any thermometer must 0.2"C or better over the duration of a treatment.

5.3. All thermometers must be calibrated against a temperature standard which is accurate to 0 ~ 2 C traceable to a National Standard. This calibration could be made and by using at least two calibrated mercury thermometers and a stirred water-bath with appropriate temperature uniformity and stability. 42 * 5-43 * 5"C .
5.4. If a thermometer is calibrated at a single point this must be within the range

5.5. Multi-sensor (linear array) probes or thermal-mapping (pull-back) techniques for single sensor probes should be used whenever possible.

5.6. If temperature measurements are made following a period in which the heating fields are turned off then the thermometry data acquisition system should be capable of scanning all sensors within 1 second (see 8.4).Care must be taken to ensure good thermal contact between sensors and the surrounding tissue. If there is not good thermal contact, excessive heating of the sensor and residual artefact may be present following the 2-3

425 second period between power-off and scanning of the sensors due to the relatively long time constant of the sensor in this situation.

Quality assurance guidelines for ESHO protocols

5.7. The probe wall must be non-metallic to prevent excessive heating of the probe in electromagneticfields and the high risk of burning the patient. Non-metallic walls also provide electrical isolation between the thermometry system and the patient. Thermometer probes must be electrically floating. The maximum leakage current must be less than 10 pA and the isolation barrier must be at least 4 kV. All hyperthermia equipment must comply with normal safety requirements for medical equipment (e.g. IEC Regulation 601). Electrical safety is of the utmost importance.
5.8. Multi-sensor thermocouple probes should be constructed from manganin and constantan (rather than copper and constantan) to reduce thermal conduction along the probe. Possible errors arising from the use of multi-sensor probes in temperature gradients should be investigated by testing these probes in a temperature step-function (Fessenden er al. 1984, Dickinson 1985).
6. Characterization of applicators 6.1. The effective field size (EFS) of an applicator is defined by the 50% SAR contour measured at a depth of 10 mm from the surface of a plane homogeneous phantom with the dielectric properties of muscle. The penetration depth (PD) is defined as the distance below 10 mm at which the SAR is 50% of that at 10 mm depth. Measurements to determine the penetration depth must be made from the position of maximum SAR at 10 mm depth.

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6.2. Both EFS and PD must be measured with the applicator arranged as the clinical set-up, including a bolus if appropriate. If a bolus is used, then its temperature should be equal to the initial temperature of the phantom. 6.3. EFS and PD should be determined by measuring the changes in temperature resulting from a brief pulse of high power. If non-perturbing E-field probes, thermographic imaging or liquid-crystal sheet imaging are used to determine SAR distributions, such measurements should be corroborated by measurements obtained using the power pulse technique. 6.4. If either a radiofrequency capacitive technique or a multi-element array of applicators is used, the EFS can depend critically on the particular geometry involved. Additional characterization of these techniques should be attempted using geometrically realistic phantoms. 6.5. When using the power pulse technique, measurements to determine the EFS and PD must be made within 60 seconds of the start of the pulse to minimize artefacts caused by thermal conduction within the phantom. 6.6. The plane muscle phantom used for determining EFS and PD must be 10 cm thick and must extend at least 5 cm beyond the physical dimensions of the applicator and bolus. In the case of radiofrequency capacitive electrodes, the thickness of the phantom should be equal to that of the tissue between the electrodes in the clinical set-up. 6.7. The muscle phantom should be made according to the details described by Chou et al. (1984). If a different type of muscle phantom is used, its dielectric properties must

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be determined and be shown to be identical to those of the Chou muscle phantom at the frequency of interest. 6.8. The efficiency of power transfer within the complete heating system (generator, coaxial cables, tuner, applicator and bolus) should be measured. The energy deposited in a phantom following a power pulse of known duration when the applicator and bolus are arranged in a clinical set-up should be determined by a calorimetric technique. The actual power delivered may be determined from the calorimetric measurements. The relationship between the actual power and that read from the systems power meters should be determined. 6.9. To ensure the safety of patients and personnel it is prudent to survey hyperthermia devices and treatment areas for hazardous electromagnetic fields. A field strength meter with an isotropic response should be used. Leakage fields from microwave applicators depend upon the area of contact between tissue and applicator and, for linearly polarized applicators, upon relative orientation between the E-field and the tissue. Since there is no consensus on recommended limits for exposure to radiofrequency electromagnetic fields, individuals should be aware of national guidelines. A summary of some guidelines is given by Hand and James (1986).

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7. The bolus system 7.1. The presence of a bolus may cause significant changes to the EFS of an applicator. The EFS recorded must be that corresponding to the clinical set-up (see 6.2).
7.2. The operator should ensure that there is good thermal contact between the bolus and skin. Particular care should be taken at positions where invasive probes are inserted and in high risk areas such as scar tissue. 7.3. The temperature within the bolus should be measured during treatment.

8. Control and data acquisition systems 8.1. A computerized control and data acquisition system should be used.
8.2. All temperature sensors should be scanned at 10-20 second intervals. Each scan should be completed within 1 second (see 9.4). 8.3. Temperature recorded by all sensors must be printed at 1 minute intervals during a treatment. These data must be kept and should be available for inspection at a later date if necessary (see 9.5).
8.4 Power levels should be monitored at 10-20 second intervals. Power readings should be printed at 10 minute intervals during treatment. These data should be kept.

8.5. Safety routines should be incorporated to prevent overheating the patient. In the event of a control thermometer failing, heating fieIds should be turned off automatically. In the event of the computer failing, heating fields should be turned off automatically.
9. Appendices 9.1. SAR distributions in anatomically-real geometries. To date there is a paucity of information concerning SAR distributions in anatomically-real geometries. Only a few centres are in a position to attempt the calculation of SAR in 3dimensions for such complex

Quality assurance guidelines for ESHO protocols

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geometry. In general, 2-dimensional calculations fail to provide a true picture of SAR distributions in 3-dimensional inhomogeneoustissues. It is important, therefore, to collect information concerning SAR distributions by making measurements during clinical treatments using either 'power pulse' or 'thermal decay' techniques (Roemer et al. 1985). The relationships between the heating system used, the tumour, anatomy and the resulting SAR distribution will be invaluable to the future development and optimization of heating systems.
9.2. Adequate heating of peripheral regions of tumours. In almost all local hyperthermia treatments we are presented with superficial tumours surrounded by well perfused normal tissue. Many of the applicators used produce a greater SAR beneath their central region than in peripheral regions and in many cases the EFS is considerably smaller than the area determined by the physical dimensionsof the applicator. In addition, limited penetration is often a problem. Use of a small applicator is likely to achieve therapeutic temperatures only in the central regions of the tumour with inadequate heating at the tumour periphery. The problem might be reduced by choosing an applicator which will provide the largest practical EFS or by using a multi-element array applicator. The EFS of the applicator chosen should extend typically 3-5 cm beyond the lateral margins of the tumour. By heating some normal tissue, the uniformity of the temperature distribution should be improved since more of the vasculature will be heated (Lagendijk, 1987). 9.3. Thermocouple and thermistor probes. Thermocouple wires should be as thin as possible (typically 40 pm) and junctions should be made as small as possible. Likewise, thermistor probes should be as small as possible. Thermocouples and thermistors should be placed within plastic (e.g. Nylon, Teflon) tubing to provide electrical isolation from the tissues. Probes should be orientated perpendicular to the direction of the E-field. If this is not possible, then potential hot-spots and artefacts should be investigated. Temperature measurements should be made in the absence of heating fields. A cycle of 10-20 seconds power-on and 2-3 seconds power-off should be used. Local heating of the probe can be measured by comparing the temperatures monitored at the end of the periods of power-on and power-off. It is useful to normalize such temperature differences to the applicator power. Values less than 0.01 "C per Watt are acceptable. Good thermal contact between the sensor and the tissue should be ensured. 9.4. Data acquisition rate. In general, the rate of decrease in temperature in tumour tissue observed when the heating field is turned off is on the order of 0 . 1 "C per second. Thus temperature measurements should be made quickly to avoid a significant underestimation of the true temperature. The data acquisition system should be capable of scanning all temperature sensors within 1 second. 9.5. Data storage. All temperatures must be reported at 1 minute intervals throughout a treatment and printed on paper. Power measurements should be recorded at the same times and printed on paper. Since data stored on magnetic discs may be corrupted or lost, storage of this information on disc must be considered to be additional and must not replace the printed data. All data must be kept and should be available for inspection at a later date if necessary. 9.6. Use of thermal isoeffect dose. When thermal isoeffect dose is used then the number of equivalent minutes at 43C must be calculated from the following formula:

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Thermal isoeffect dose (in equivalent minutes at 43"C)=

treatment

Atq (t)

428

@T-transition) where .At if T< transition and transition=42 5"C, T=current temperature, At=period in minutes between temperature measurements (see 8.2). It is stressed that the use of thermal isoeffect dose should be restricted to individual treatments.

J. W. Hand et al. ( T )=2(T-43). At if ~2 transition or cq ( T )=2(transition-43) eq

Acknowledgements We thank all colleagues who provided information either by responding to a questionnaire, by attending workshops held during 1987 in Utrecht and Cardiff or by commenting on draft versions of the guidelines. In particular we acknowledge the advice and assistance of Dr J. van Dijk, Mr E. Gross, Mr R. G. F. Knol, Dr P. Nilsson and Dr J. Overgaard.
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References
CHOU, K., CHEN,G.W., GUY,A. W., and LUK,K. H., 1984, Formulas for preparing phantom C. muscle tissue at various radiofrequencies. Bioelectromagnerics, 5 , 435-441. DICKINSON, J., 1985, Thermal conduction errors of manganin-constantan thermocouple arrays. R. Physics in Medicine and Biology, 30, 445-453. ESHO, 1986, European Society for Hyperthermic Oncology protocols (3rd Edition). Study coordinator: J. Overgaard, Institute of Cancer Research, DK-8000Aarhus C. T. FESSENDEN, SAMULSKI, V., and LEE, E. R., 1984, Direct temperature measurement. Cancer P., Research, 44 (sup) 4799s-4804s. HAND, W. and, JAMES, R., 1986, Physical Techniques in Clinical Hypenhermia. (Research J. J. Studies Press, Letchworth, UK), pp. 23-28. LAGENDUK, J. W., 1987, Heat transfer in tissues. In Physics and Technology of Hyperthermia, J. Edited by S . B. Field and C. Franconi, (Martinus Nijhoff, Dordrecht), pp. 517-552. ROEMER, B., FLETCHERM. and CETAS, C. 1985, Obtaining local SAR and blood perfusion R. A. T. data from temperature measurements: steady state and transient techniques compared. International Journal of Radiation Oncology, Biology and Physics, 11, 1539- 1550.