Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Description

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Akron

Cleveland Clinic Akron General, Case Comprehensive Cancer Center, Akron, Ohio, United States, 44302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    FEMALE

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Case Comprehensive Cancer Center,

    Andrew Fenton, M.D., PRINCIPAL_INVESTIGATOR, Cleveland Clinic Akron General, Case Comprehensive Cancer Center

    Study Record Dates

    2026-11