A Trial of RSL Versus WL for Malignant Breast Disease
BCS-RSL-001
A Randomized Single-Center Superiority Trial of Radioactive Seed Localization Versus Needle Localization for Malignant Breast Disease.
1 other identifier
interventional
400
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2015
CompletedFirst Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedAugust 10, 2022
January 1, 2022
5.5 years
July 28, 2015
August 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Radioactive Seed Localization
EXPERIMENTALRadioactive Seeds
Wire Localization
ACTIVE COMPARATORWire
Interventions
Eligibility Criteria
You may qualify if:
- Female
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Lejla Hadzikadic-Gusic, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2015
First Posted
August 13, 2015
Study Start
July 24, 2015
Primary Completion
January 21, 2021
Study Completion
February 23, 2021
Last Updated
August 10, 2022
Record last verified: 2022-01