A Trial of RSL Versus WL for Malignant Breast Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-24

Study Completion Date

2021-02-23

Brief Summary

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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).

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Detailed Description

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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

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Breast- Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radioactive Seed Localization

Radioactive Seeds

Group Type EXPERIMENTAL

Radioactive Seed Localization

Intervention Type PROCEDURE

Wire Localization

Wire

Group Type ACTIVE_COMPARATOR

Wire Localization

Intervention Type PROCEDURE

Interventions

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Radioactive Seed Localization

Intervention Type PROCEDURE

Wire Localization

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No