A Trial of RSL Versus WL for Malignant Breast Disease

Not Applicable

Completed

• Conditions: Breast- Female
• Interventions: Procedure: Radioactive Seed Localization; Procedure: Wire Localization

• Registration Number: NCT02522468
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07-24
• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2021-01-21
• Study Completion: 2021-02-23
• Status Verified: 2022-01
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radioactive Seed Localization	Radioactive Seed Localization	Radioactive Seeds
Wire Localization	Wire Localization	Wire

Primary Outcome Measures

Name	Time	Method
Surgical Resection Margins	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).

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States