Guidelines by the AAPM and GEC‐ESTRO on the use of innovative brachytherapy devices and applications: Report of Task Group 167

Abstract

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used in the evaluation of innovative devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining the equivalence of the innovative treatment modality to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of innovative radiotherapy devices or applications is a critical part in which physicists should be actively involved. The physicist's role, along with physician colleagues, in this process is highlighted for innovative brachytherapy devices and applications and includes evaluation of (1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, (2) risks and benefits from a regulatory and safety perspective, and (3) resource assessment and preparedness. Further, it is suggested that any developed calibration methods be traceable to a primary standards dosimetry laboratory (PSDL) such as the National Institute of Standards and Technology in the U.S. or to other PSDLs located elsewhere such as in Europe. Clinical users should follow standards as approved by their country's regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the Accredited Dosimetry Calibration Laboratories in the U.S. is encouraged before a source is introduced into widespread routine clinical use. The American Association of Physicists in Medicine and the Groupe Européen de Curiethérapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) have developed guidelines for the safe and consistent application of brachytherapy using innovative devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. Nuclear Regulatory Commission, U.S. Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, U.S. Food and Drug Administration, European Commission for CE Marking (Conformité Européenne), and institutional review boards and radiation safety committees.

A directional 103Pd brachytherapy device: Dosimetric characterization and practical aspects for clinical use

“…Given the design differences between the CivaDot and conventional seeds (and subsequent need to develop an approach strictly differing from the TG-43 dose calculation formalism), it was rewarding to determine a solution compatible with the TPS dose calculation algorithm to permit accurate determination of the planned dose distribution. As a novel BT source, the process of TPS data entry and commissioning for the CivaDot was the same as for a conventional LDR BT seed (15). The simulation results were distilled into a dataset that had linear and bilinear interpolation errors of g TPS ( r ) and F TPS ( r , θ ) that were less than 2% for TPS entry.…”

“…As for any new BT device, a robust evaluation should be performed that includes careful analysis of its dosimetry (15). Radiation oncologists should in advance have a good sense for the potential physical affect of the device, which is largely based on the dosimetry for BT sources.…”

“…The American Association of Physicists in Medicine (AAPM) has set standards for dosimetric characterization and the calibrations of new BT sources (4,14,15). While the calibration aspects have been recently addressed by Aima and colleagues (16), there still was a need for clinics to have the necessary dosimetric information to facilitate treatment planning.…”

Comparison of 192Ir, 169Yb, and 60Co high‐dose rate brachytherapy sources for skin cancer treatment

“…Currently, there are various 192 Ir‐based HDR remote after‐loading systems available in the market . In addition, new interest in the use of other HDR sources, either with high energy sources (e.g., 60 Co in the ECKERT & Ziegler BEBIG GmbH afterloading machine) and/or middle energy sources (e.g., 169 Yb with dual‐source Flexitron after‐loading system) are being developed.…”

Inter-Fraction and Intra-Fraction Variation in the Absorbed-Dose Delivery during Interstitial High Dose Rate Brachytherapy—A Study Using MicroMOSFET <i>In-Vivo</i> Dosimeter

“…The advantage of Brachytherapy is the higher degree of dose localization in the target volume with better dose sparing of normal tissue [1]. Interstitial Brachytherapy, an invasive form of Brachytherapy, offers a flexible way of customized treatment for the patient, and is usually chosen as a radical treatment for the early-stage Head & Neck cancers, Breast Cancers and for Soft Tissue Sarcoma (STS) [2].…”