"The Efficacy of 'Radioguided Occult Lesion Localization' (ROLL) Versus 'Wire-guided Localization' (WGL) in Breast Conserving Surgery for Non-palpable Breast Cancer: a Randomized Clinical Trial"

Rationale: Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (wire guided localization \[WGL\]) is difficult to perform and has a high rate of tumour positive margins in the resected specimen, requiring a second operation. A new approach in the localization and resection of non-palpable malignant breast lesions is 'radio guided occult lesion localization' (ROLL). ROLL was introduced as a possible replacement for WGL at the 'European Institute of Oncology' in Milan in 1996. This technique utilizes the intratumourally injected radiotracer, that is generally used for the lymphatic mapping and SNB, to localize the primary tumour guided by the gamma probe. Five studies so far have proven the applicability of this method. Objective: To evaluate the efficacy of Radio Occult Lesion Localisation (ROLL) versus Wire guided Localisation (WGL) in breast conserving surgery for non-palpable breast cancer Study design: A multicenter, prospective randomized clinical trial. Patients with proven non-palpable breast cancer will be randomized for either ROLL or WGL. Study population: 316 women with a core biopsy proven non palpable cT1 breast carcinoma that are eligible for a breast conserving treatment and sentinel node biopsy (SNB). Intervention (if applicable): Patients in the WGL group will undergo intra tumoural injection of a nuclear radiotracer under stereotactic or ultrasonographic guidance. After scintigraphic imaging, to monitor the migration of the radiotracer, a guide wire will be inserted under stereotactic or ultrasonographic guidance. The excision of the primary tumour is guided by the inserted wire and the sentinel node procedure is performed using a gamma probe and intratumoural injection of patent blue. Patients in the ROLL group will undergo the same procedure except for the guide wire insertion. The excision of the primary