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Shave Margins in Breast Conservation Therapy

NCT02462200 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-06-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Julie Margenthaler, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-13
Primary Completion
2019-11-27
Completion
2019-11-27

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02462200 on ClinicalTrials.gov