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Breast Biopsy: Multicenter Study of Radiofrequency Introducer with US-guided Handheld System—Initial Experience¹

¹ From the Department of Radiology, Hôpital du Saint-Sacrement, Québec City, Canada (N.D.); Sally Jobe Breast Center, Englewood, Colo (S.H.P.); Department of Radiology, Community General Hospital, Syracuse, NY (A.J.K.); and Seno Rx, Aliso Viejo, Calif (M.L.M.). From the 2001 RSNA scientific assembly. Received December 7, 2001; revision requested February 20, 2002; final revision received December 15, 2003; accepted January 5, 2004. Supported by SenoRx. Address correspondence to N.D., Ottawa Regional Women’s Breast Health Center, 200 Melrose Ave, Ottawa, ON, Canada KIY 4K7 (e-mail: nduchesne@ottawahospital.on.ca).

PURPOSE: To evaluate the utility of a radiofrequency (RF) introducer in placement and use of a handheld breast biopsy system during ultrasonography (US)-guided breast biopsy.

MATERIALS AND METHODS: In three institutions from September 2000 through June 2001, 99 patients were scheduled for US-guided breast biopsy with the handheld system. Patients were randomly assigned to undergo biopsy with the handheld system alone (control group, 50 patients) or with the RF introducer and the handheld system (treatment group, 49 patients). Investigators compared the ability of the radiologist and pathologist to obtain a histologic diagnosis, ease of tissue penetration, procedure time, and pain. Patients assessed their pain level after the procedure and at 1, 7, and 30 days after biopsy.

RESULTS: The RF introducer provided easier penetration (treatment group mean score, 1.6; control group, 2.4), particularly in patients with dense breasts (treatment group, 1.0; control group, 2.9) on the basis of a five-point scale (1 = very easy, 5 = extremely difficult). A histologic diagnosis was obtained in all cases, and no RF-induced artifact was reported. Average biopsy procedure time for treatment and control groups was not significantly different. Average patient pain levels were comparable between groups for each evaluation interval. Clinical complications in four treatment patients and three control patients were minor and resolved spontaneously.

CONCLUSION: The RF introducer may serve as a useful adjunct to the handheld biopsy system by facilitating penetration of breast tissue without causing any deleterious effects for the patient or the biopsy specimen.

© RSNA, 2004

Index terms: Biopsies, technology, 00.1261, 00.12985 • Breast, biopsy, 00.1261, 00.12985, 00.30 • Breast neoplasms, diagnosis, 00.30 • Radiofrequency (RF) ablation, 00.1269 • Ultrasound (US), guidance, 00.12985