NCT02522468

A Trial of RSL Versus WL for Malignant Breast Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast- Female

Interventions

Type	Name	Description
PROCEDURE	Radioactive Seed Localization
PROCEDURE	Wire Localization

Timeline

• Start date: 2015-07-24
• Primary completion: 2021-01-21
• Completion: 2021-02-23
• First posted: 2015-08-13
• Last updated: 2022-08-10

Locations

1 site across 1 country: United States