A Trial of RSL Versus WL for Malignant Breast Disease (BCS-RSL-001)
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The purpose of this randomized trial is to determine the superiority of utilizing radioactive seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable malignant lesions in patients undergoing breast conservation surgery (BCS).
Consented and eligible subjects will be randomized to either radioactive seed localization or wire localization and stratified by surgeon and invasive versus DCIS prior to localization. Subjects on both arms will undergo breast conservation surgery including surgical specimen removal. Specimens will be grossed according to standard of care procedures. Localization, breast conservation surgery, and post-operative appointments will follow standard of care guidelines. Surveys will be administered according to the study calendar to the radiologist, surgeon, pathologist, and subject for data collection.
Surgical Resection Margins [ Time Frame: 30 days ]
The primary objective for this study will be the comparison between Radioactive Seed Localization (RSL) and Wire-Guided Localization (WL) based on negative margins in malignant breast disease. This is defined as no tumor on ink in invasive disease and greater than or equal to 2mm from the inked margin in non-invasive disease (DCIS).
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Ages Eligible for Study:
20 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
20 to 99 years of age
Breast lesion necessitating image-guided excision
Biopsy-proven malignant breast lesion including by not limited to invasive ductal carcinoma, invasive lobular carcinoma, and ductal carcinoma in situ
Signed written informed consent document by the subject and/or a LAR
Multifocal or multicentric disease
Receiving neoadjuvant chemotherapy
Pregnant or breastfeeding
Locally advanced disease
Breast conservation contraindication such as inability to receive whole breast radiation therapy, inability to tolerate localization procedure, inability to lay flat or prone for radiation, and undesirable tumor to breast ratio
Prior breast cancer on ipsilateral side
Unable or unwilling to adhere to post-localization instructions (e.g. timely seed removal)