A Trial of RSL Versus WL for Malignant Breast Disease

Study Overview
=================
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.

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

Conditions
-----------------
Breast- Female

Intervention / Treatment
-----------------
* Procedure: Radioactive Seed Localization
* Procedure: Wire Localization


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radioactive Seed Localization<br>Radioactive Seeds | Procedure: Radioactive Seed Localization<br> <br> |
| Active Comparator: Wire Localization<br>Wire | Procedure: Wire Localization<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |