Randomized clinical trial comparing radioisotope occult lesion localization and wire-guided excision for biopsy of occult breast lesions

Background: Accurate localization of impalpable breast lesions that require biopsy is important. This randomized trial compared radioisotope occult lesion localization (ROLL) with the standard hooked-wire technique. Methods: Ninety-five patients were randomized to receive either ROLL or wire localization of an occult breast lesion. Correct placement of isotope was confirmed by mammography and a hand-held gamma probe was used to guide the surgical excision. Radiological, surgical and pathological data were compared for accuracy, duration and ease of technique, and histopathological. diagnosis. Procedure-related pain was also assessed. Results: Of the 95 patients entered, 48 were randomized to ROLL and 47 to mire localization. Two ROLL procedures failed. Marking was accurate in 46 of 48 ROLL procedures and 44 of 47 of wire localizations (P = 0.242). Difficulty in localization (Likert score 2.6 for ROLL versus 4.4 for wire localization; P < 0.001) and the degree of surgical difficulty (2.6 versus 4.0; P < 0.001) were significantly less for ROLL. ROLL was associated with less pain (score 2.7 versus 3.6; P = 0.012). There were no significant differences in mean duration of operation, specimen weight, need for intraoperative re-excision or second therapeutic operation. Conclusion: ROLL and wire-guided localization were similarly effective for breast biopsy, but ROLL was easier for both radiologist and surgeon, and less painful for the patient.