European quadricentric evaluation of a breast MR biopsy and localization device: technical improvements based on phase-I evaluation

Our purpose was to report about technical success, problems and solutions, as experienced in a first multicentre study on MR-guided localisation or vacuum biopsy of breast lesions. The study was carried out at four European sites using a dedicated prototype breast biopsy device. Experiences with 49 scheduled localisation procedures and 188 vacuum biopsies are reported. Apart from 35 dropped indications, one localisation procedure and 9 vacuum biopsies were not possible (3 times space problems due to obesity, 2 times too strong compression, 3 times impaired access from medially, 2 times impaired access due to a metal bar). Problems due to too strong compression were recognised by repeat MR without compression. During the procedure problems leading to an uncertain result occurred in eight vacuum biopsies, two related to the procedure: one limited access, and one strong post-biopsy enhancement. Improvements after phase-I study concerned removal of the metal bar, development of an improved medial access, of a profile imitating the biopsy gun, optimisation of compression plates and improved software support. The partners agreed that the improvements answered all important technical problems.