Breast Cancer Clinical Trial
A Trial of RSL Versus WL for Malignant Breast Disease
Summary
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).
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Female
20 to 99 years of age
Breast lesion necessitating image-guided excision
Unifocal disease
Breast-conservation candidate
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
Exclusion Criteria:
Male
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)
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There is 1 Location for this study
Charlotte North Carolina, 28204, United States
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