NCT02462200

Shave Margins in Breast Conservation Therapy

Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

• Breast Cancer
• Cancer of Breast
• Cancer of the Breast

Interventions

Type	Name	Description
PROCEDURE	Breast-conserving surgery (BCS)
PROCEDURE	Cavity shave margins (CSM)
BEHAVIORAL	BREAST-Q Questionnaire
DEVICE	3-D breast imaging	Using a 3-D breast imaging camera Vectra 3-D XT
OTHER	Indocyanine green
DEVICE	Intraoperative imaging device	The goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field
PROCEDURE	Peripheral blood draw	-Time of surgery if coordinator is available

Timeline

• Start date: 2016-06-13
• Primary completion: 2019-11-27
• Completion: 2019-11-27
• First posted: 2015-06-03
• Last updated: 2020-06-25

Locations

1 site across 1 country: United States