Clinical trial · Interventional
Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. | Procedure | — | UNRESOLVED |
| Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Partial mastectomy with Savi Scout® localization and routine cavity shave margins
- interventionNames
- Procedure: Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Partial mastectomy with Savi Scout® localization and selective shave margins.
- interventionNames
- Procedure: Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.
Primary outcomes (1)
- measure
- Determine the difference in positive margin rate between the two methods.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 pathologically confirmed breast carcinoma or ductal carcinoma in situ. * Performance status: ECOG 0-1 * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Patients may have received or may be receiving endocrine therapy. Exclusion Criteria * Men * Pregnant women * Patients who have received neoadjuvant chemotherapy for current cancer diagnosis. * Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.) * Patients \< 18 years of age.
References
Publications (0)
Data not yet available