Multicenter clinical experience with large core soft tissue biopsy without vacuum assistance

The increasing interest in accurate pretreatment diagnosis of solid tumours by morphology, immunohistochemistry, genetics and molecular biology requires clinicians to obtain undamaged large core biopsies. Simultaneously, medical imaging and surgery give priority to minimal tissue injury, affordable technology and optimal patient compliance. A new large core soft tissue biopsy device has been developed to meet the above criteria. After intensive preclinical testing, 30 patients gave informed consent and 26 underwent the new diagnostic biopsy procedure. The sample was studied by morphology, immunohistochemistry and, where indicated, by molecular biology. Successful diagnosis was considered when in line with clinical follow-up and, as for all malignant lesions, when confirmed by open biopsy or surgery. No difficulties in the technique were encountered in 25 patients. In one patient the procedure was prematurely stopped because of anxiety. In all other 25 procedures a complete diagnosis was reached with regard to morphology, immunohistochemistry and molecular biology. A number of radiologists suggested some automation of the technique. This new large core soft tissue biopsy system performs well in the clinical context without injury to the breast parenchyma or artefacts in the harvested tissue specimen. The system meets almost all of the proposed technical and financial requirements. Automation is underway.