IRB Study Number 23-502
Status Recruiting
Location Akron General
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
The primary objective is to determine the difference in positive margin rate between partial mastectomy with shave margins and Savi Scout localization and partial mastectomy with selective margins and Savi Scout localization.
2.2 Secondary Objectives
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.
Inclusion Criteria
• Women 18 years and older, and
• With Clinical stage I-II invasive breast cancer, or
Stage 0 DCIS, and
• That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and
• Present to Cleveland Clinic Akron General.
• Subjects must have histologically or cytologically confirmed breast carcinoma or ductal carcinoma in situ.
• Subjects must have received no prior therapies for this disease.
• Performance status: ECOG 0-1
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
• Pregnant women
• Patients who:
a. Have a history of excisional biopsy, partial mastectomy, or other surgical intervention, except needle biopsy, on the ipsilateral breast.
b. Have history of chest radiation to the ipsilateral breast.
c. Have received neoadjuvant chemotherapy or endocrine therapy for current cancer diagnosis.
d. Were diagnosed with synchronous bilateral breast cancer. Patients who were diagnosed with asynchronous breast cancer on the contralateral breast at least one year prior to current diagnosis are eligible.
e. Are < 18 years of age.
