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Cryoablation of Early Invasive Ductal Breast Cancer With MRI Confirmation Shows Promising Clinical Benefits, According to Study Presented at RSNA

Saturday, December 6, 2008 General News J E 4
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CHICAGO, Dec. 5 Early clinical experience with the FDAcleared Visica 2(TM) Treatment System from Sanarus Medical confirms theeffectiveness of ultrasound guided cryoablation to completely eradicatesmall, unifocal Invasive Ductal Breast Cancer (IDC). Initial data from thismulti-center study was presented at the 94th Scientific Assembly and AnnualMeeting of the Radiological Society of North America (RSNA), November 29 -December 5, 2008.

The study, "New Findings on Contrast-enhanced Magnetic ResonanceImaging, the "Black Hole" and "Cryohalo" are Markers for the Efficacy ofUltrasound-guided Cryoablation of Small Unifocal Invasive Ductal BreastCancer," presented by Gary Levine, MD, Director of Breast Imaging at HoagBreast Care Center in Newport Beach, Calif., was designed to evaluate theability of breast contrast enhanced MRI to assess the effectiveness ofultrasound guided cryoablation for the local treatment of small, unifocal IDC.

"With a large body of evidence demonstrating the ability of cryoablationto destroy cancerous and noncancerous tumors of the liver, prostate, kidneyand breast, the gating factor for the treatment of breast cancer tumors wasthe ability to visualize the extent of the tumor in advance and confirm targetdestruction post-procedure," said Dr. Levine. "We are very encouraged thatour preliminary results demonstrate that in selected early IDC breast cancers,cryoablation with MRI confirmation may offer the same therapeutic benefit aslumpectomy with less morbidity, improved cosmesis and less cost."

Patients with newly diagnosed IDC underwent an "early" pre-ablation CEMRIto establish its MR enhancement pattern. Ultrasound-guided cryoablation wasthen performed using a Visica Treatment System to ablate the malignant tumorand a margin of surrounding tissue. A "delayed" CEMRI was performedapproximately four weeks post-ablation followed by a standard surgicallumpectomy. The early and delayed CEMRI findings were correlated with thesurgical histopathology. In all 15 cases, the post-ablation MRI's showed nosuspicious contrast enhancement remaining at the targeted tumor site andhistopathology confirmed complete tumor kill within the intended ablationzone. In three cases histopathology confirmed residual DCIS and/or smallsatellite lesions outside the cryoablation zone.

At delayed CEMRI, previously unreported characteristic and reproduciblefindings of signal void on post-contrast subtraction images ("black hole")correlates with an area of coagulation necrosis at the cryoablation site and asurrounding uniform thin rim enhancement ("cryohalo") corresponds to a zone ofinflammation at the cryoablation margin.

"Lack of residual suspicious enhancement on post-cryoablation CEMRIappears to correlate with complete tumor kill within the targeted ablationzone. We believe the novel MR findings termed "black hole" and "cryohalo"serve as markers for successful ablation, giving us a noninvasive andreproducible method to verify clinical results," added Dr. Levine.

The study conducted by Dr. Levine and Steven Poplack, MD, Co-Director ofBreast Imaging at Dartmouth Hitchcock Medical Center is similar to theNational Cancer Institute (NCI) funded clinical trial recently initiated bythe American College of Surgeons Oncology Group (ACOSOG). Titled, "A Phase IITrial Exploring the Success of Cryoablation Therapy in the Treatment ofInvasive Breast Carcinoma," the ACOSOG study will also evaluate cryoablationas well as the ability of MRI to evaluate post-cryoablation efficacy. TheVisica 2 System was selected as the exclusive cryoablation technology to beutilized in the ACOSOG study.

Cryoablation is a minimally invasive non-surgical procedure that usesextreme cold to destroy tumors. The Sanarus Visica System has predominatelybeen used in the cryoablation of non-cancerous tumors called fibroadenomassince its initial FDA market clearance in March of 2002. This office-basedprocedure, which usually takes less than 20 minutes, involves placing a smallneedle into the center of the fibroadenoma using ultrasound guidance andsubsequently freezing and killing the tumor. The safety and efficacy ofcryoablation have been well established in over 2,000 fibroadenomas that havebeen treated with the System to date.

This study was presented at RSNA as part of the Breast Imaging(Interventional) Session, #SST01-05, Friday, December 5 at 11:10am in RoomE253CD:

New Findings on Contrast-enhanced Magnetic Resonance Imaging (CEMRI),the "Black Hole" and "Cryohalo" are Markers for the Efficacy of Ultrasound(US)-guided Cryoablation of Small (less than or equal to 15mm) UnifocalInvasive Ductal Breast Cancer

GLevine, FSHeinemann, Hoag Breast Care Center, Newport Beach, CA;SPoplack, RBarth, WWells, Dartmouth Hitchcock Medical Center, Lebanon, NH

About Sanarus Medical

Sanarus Medical is based in Pleasanton, Calif., and is focused onproviding patients and physicians with minimally invasive, office-based breastcare management solutions from diagnosis to treatment. Using cryoablationtechnology, Sanarus has developed proprietary technologies to provide breastsurgeons and radiologists with a comprehensive and minimally invasive way todiagnose and treat breast patients. The Sanarus technologies change the waythat patients are managed, from an operating room-based, surgically intensivecare pathway to a more comfortable, cost effective, office-based care pathway.The company's Website is http://www.sanarus.com.

SOURCE Sanarus Medical, Inc.
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