A Trial of RSL Versus WL for Malignant Breast Disease

Breast- Female Clinical Trial

— BCS-RSL-001  

Official title:

A Randomized Single-Center Superiority Trial of Radioactive Seed Localization Versus Needle Localization for Malignant Breast Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522468
• Other study ID #: LCI-BRE-BCS-RSL-001
• Status: Completed
• Phase: N/A
• Start date: July 24, 2015
• Est. completion date: February 23, 2021

Study information

• Verified date: January 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 23, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Diseases
• Breast- Female

Intervention

Procedure:
• Radioactive Seed Localization

• Wire Localization

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Resection Margins	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).	30 days