A technical evaluation of the Nucletron FIRST system: Conformance of a remote afterloading brachytherapy seed implantation system to manufacturer specifications and AAPM Task Group report recommendations

Abstract

ABSTRACT: The Fully Integrated Real-time Seed Treatment (FIRST?) system by Nucletron has been available in Europe since November 2001, and is becoming increasingly used in Canada and the United States. Like the conventional transrectal ultrasound implant procedure, the system utilizes an ultrasound probe, needles, and brachytherapy seeds. However, this system is unique in that it: (i) utilizes a low dose rate brachytherapy seed remote afterloader (the seedSelectron), (ii) utilizes 3-D image reconstruction acquired from electromechanical controlled, non-stepping rotation of the ultrasound probe, (iii) integrates the control of a remote afterloader with electromechanical control of the ultrasound probe for integrating the clinical procedure into a single system, and (iv) automates the transfer of planning information and seed delivery to improve quality assurance and radiation safety. This automated delivery system is specifically intended to address reproducibility and accuracy of seed positioning during implantation. The FIRST computer system includes two software environments (SPOT PRO? and seedSelectron?). Both are used to facilitate treatment planning and brachytherapy seed implantation from beginning to completion of the entire procedure. In addition to these features, the system is reported to meet certain product specifications for seed delivery positioning accuracy and reproducibility, seed calibration accuracy and reliability, and brachytherapy dosimetry calculations. Consequently, a technical evaluation of the FIRST System was performed to determine adherence to manufacturer specifications, and to determine adherence to the AAPM Task Group Reports. 43, 53, 56, 59, 64 and recommendations of the American Brachytherapy Society (ABS). The United States Nuclear Regulatory Commission (NRC) has recently added Licensing Guidance for seedSelectron system under 10 CFR 35.1000. References for adherence to licensing guidance is made in reference to applicable AAPM Task Group recommendations. In general, results of this evaluation indicated the system met its claimed specifications, and also met the applicable recommendations outlined in the AAPM and ABS reports.