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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02522468
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : October 29, 2018
Information provided by (Responsible Party):
Lejla Hadzikadic-Gusic, Carolinas Healthcare System

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).

Condition or disease Intervention/treatment Phase
Breast- Female Procedure: Radioactive Seed Localization Procedure: Wire Localization Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Single-Center Superiority Trial of Radioactive Seed Localization Versus Needle Localization for Malignant Breast Disease.
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: Radioactive Seed Localization
Radioactive Seeds
Procedure: Radioactive Seed Localization
Active Comparator: Wire Localization
Procedure: Wire Localization

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02522468

Contact: Sapana Shah

United States, North Carolina
Carolinas Healthcare System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Whitney Stanley    980-442-2337      
Sponsors and Collaborators
Lejla Hadzikadic-Gusic
Principal Investigator: Lejla Hadzikadic-Gusic, MD Carolinas Healthcare System

Responsible Party: Lejla Hadzikadic-Gusic, MD, Carolinas Healthcare System Identifier: NCT02522468     History of Changes
Other Study ID Numbers: LCI-BRE-BCS-RSL-001
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases