AAPM Task Group on Recommendations on Dosimetry Requirements for Investigational Sources for Interstitial Brachytherapy
- To review the current practice in the marketplace, current FDA requirements for new brachytherapy sources and the difficulties encountered regarding the dosimetry of novel brachytherapy sources for permanent implantation using examples such as the historical introduction of TheraSeed by Theragenics™ and more recently Cs-131 by IsoRay Medical™.
- To review critical physical, dosimetric and radiobiological issues that arise when a novel source is introduced for permanent interstitial brachytherapy such as calibration traceability, accuracy of dosimetry parameters, choice of prescribed dose for equivalent results. Also, the need to receive pertinent information about the source design from the manufacturer will be outlined so that a proper evaluation of a novel source can be accomplished. The primary focus of this task group will be on prostate implantation.
- To develop consensus guidelines on the methodology for these dosimetry issues that can minimize the potential risk to the human subjects and maximizes the efficiency with which these novel sources can be widely adopted for the benefit of cancer patients. The overall objective is to highlight the critical issues and missing information that may affect the clinical response so that investigators address them as a deliberate part of their study design.