Clinical trial · Interventional
Shave Margins in Breast Conservation Therapy
Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient funding
Summary
Brief summary (as posted)
The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. A parallel group format will be implemented to compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of care.
Conditions
Conditions (3)
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 |
| Cancer of Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-D breast imaging | Device | — | UNRESOLVED |
| Breast-conserving surgery (BCS) | Procedure | — | UNRESOLVED |
| BREAST-Q Questionnaire | Behavioral | — | UNRESOLVED |
| Cavity shave margins (CSM) | Procedure | — | UNRESOLVED |
| Indocyanine green | Other | — | UNRESOLVED |
| Intraoperative imaging device | Device | — | UNRESOLVED |
| Peripheral blood draw | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BCS Arm (breast-conserving surgery - standard of care)
- description
- * Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization * The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use). * Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
- interventionNames
- Procedure: Breast-conserving surgery (BCS)
- Behavioral: BREAST-Q Questionnaire
- Device: 3-D breast imaging
- Other: Indocyanine green
- Device: Intraoperative imaging device
- Procedure: Peripheral blood draw
- type
- EXPERIMENTAL
- label
- CSM Arm (breast-conserving surgery with cavity shave margins)
- description
- * Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained * A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation * The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies). * Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, biopsy-proven stage 0-II breast cancer. * Planning to undergo breast-conserving surgery. * At least 18 years of age and no more than 85 years of age. * Female. * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Prior surgical treatment for this diagnosis. * Undergone neoadjuvant chemotherapy. * History of prior chest radiation therapy. * Known metastatic disease. * Pregnant. * Preference for mastectomy instead of breast-conserving surgery. * History of ipsilateral breast cancer. * Goggle assessment substudy: Iodine or seafood allergies.
References
Publications (0)
Data not yet available