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A Trial of RSL Versus WL for Malignant Breast Disease (BCS-RSL-001)

Primary Purpose

Breast- Female

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radioactive Seed Localization
Wire Localization
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast- Female

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Levine Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radioactive Seed Localization

Wire Localization

Arm Description

Radioactive Seeds

Wire

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 28, 2015
Last Updated
August 5, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02522468
Brief Title
A Trial of RSL Versus WL for Malignant Breast Disease
Acronym
BCS-RSL-001
Official Title
A Randomized Single-Center Superiority Trial of Radioactive Seed Localization Versus Needle Localization for Malignant Breast Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2015 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast- Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radioactive Seed Localization
Arm Type
Experimental
Arm Description
Radioactive Seeds
Arm Title
Wire Localization
Arm Type
Active Comparator
Arm Description
Wire
Intervention Type
Procedure
Intervention Name(s)
Radioactive Seed Localization
Intervention Type
Procedure
Intervention Name(s)
Wire Localization
Primary Outcome Measure Information:
Title
Surgical Resection Margins
Description
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).
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lejla Hadzikadic-Gusic, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Trial of RSL Versus WL for Malignant Breast Disease

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