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.

The Fully Integrated Real-time Seed Treatment (FIRST (TM)) system by Nucletron has been available in Europe since November 2001 and is being used more and more in Canada and the United States. Like the conventional transrectal ultrasound implant procedure, the FIRST system utilizes an ultrasound probe, needles, and brachytherapy seeds. However, this system is unique in that it ( 1) utilizes a low-dose-rate brachytherapy seed remote afterloader ( the seedSelectron), ( 2) utilizes 3D image reconstruction acquired from electromechanically controlled, nonstepping rotation of the ultrasound probe, ( 3) integrates the control of a remote afterloader with electromechanical control of the ultrasound probe for integrating the clinical procedure into a single system, and ( 4) 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 T and seedSelectron T; 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 the American Association of Physicists in Medicine (AAPM) Task Group Reports 43, 53, 56, 59, and 64 and recommendations of the American Brachytherapy Society (ABS). The United States Nuclear Regulatory Commission (NRC) has recently added Licensing Guidance for the seedSelectron system under 10 CFR 35.1000. Adherence to licensing guidance is made by referencing applicable AAPM Task Group recommendations. In general, results of this evaluation indicated that the system met its claimed specifications as well as the applicable recommendations outlined in the AAPM and ABS reports.