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Early clinical experience using a Visica? Treatment System to ablate malignant tumors and a margin of surrounding tissue, confirm the effectiveness of ultrasound guided cryoablation, a minimally invasive non-surgical procedure that uses extreme cold to destroy tumors, to completely eradicate small, unifocal Invasive Ductal Breast Cancer (IDC).

Initial data from this multi-center study confirming the data was presented today during the 94th Scientific Assembly and Annual Meeting (November 30 ? December 5, 2008) of the Radiological Society of North America (RSNA).“We are very encouraged that our preliminary results demonstrate that in selected early IDC breast cancers, cryoablation with MRI confirmation may offer the same therapeutic benefit as lumpectomy with less morbidity, improved cosmesis and less cost,? said Garry Levine, M.D. Director of Breast Imaging at Hoag Breast Care Center in Newport Beach, CA.

The study was designed to evaluate the ability of breast contrast-enhanced MRI (CEMRI) to assess the effectiveness of ultrasound guided cryoablation for the local treatment of small, unifocal IDC. Patients with newly diagnosed IDC underwent an ?early? pre-ablation CEMRI to establish its MR enhancement pattern. Ultrasound-guided cryoablation was then performed using a Visica Treatment System, developed by Sanarus Medical (Pleasanton, CA), to ablate the malignant tumor and a margin of surrounding tissue.

A ‘delayed’ CEMRI was performed approximately four weeks post-ablation followed by a standard surgical lumpectomy. The early and delayed CEMRI findings were correlated with the surgical histopathology. In all 15 cases, the post-ablation MRI’s showed no suspicious contrast enhancement remaining at the targeted tumor site and histopathology confirmed complete tumor kill within the intended ablation zone. In three cases histopathology confirmed residual DCIS and/or small satellite lesions outside the cryoablation zone.

“Lack of residual suspicious enhancement on post-cryoablation CEMRI appears to correlate with complete tumor kill within the targeted ablation zone. We believe the novel MR findings termed ‘black hole’, which correlates with an area of coagulation necrosis at the cryoablation site and a surrounding uniform thin rim enhancement, and ‘cryohalo’ which corresponds to a zone of inflammation at the cryoablation margin, serve as markers for successful ablation, giving us a noninvasive and reproducible method to verify clinical results,” explained Dr. Levine.

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The study conducted by Dr. Levine and Steven Poplack, MD, Co-Director of Breast Imaging at Dartmouth Hitchcock Medical Center is similar to the National Cancer Institute (NCI) funded clinical trial recently initiated by the American College of Surgeons Oncology Group (ACOSOG).The ACOSOG study, (A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma), will also evaluate cryoablation as well as the ability of MRI to evaluate post-cryoablation efficacy.

Last editorial review: December 6, 2008.

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