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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
81
Using a 3-D breast imaging camera Vectra 3-D XT
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
-Time of surgery if coordinator is available
Washington University School of Medicine
St Louis, Missouri, United States
Proportion of patients with positive margins on pathological specimen analysis
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Patient perceptions of the surgery as measured by BREAST-Q questionnaire and novel 3-dimensional breast imaging
* The BREAST-Q questionnaire consists of 13 sections. * The sections ask the patient questions about how they feel about how their breast area looks, how they feel emotionally, any physical side effects, and sexual side effects. * Some of the sections ask the patients to answer a question on a scale of None of the Time (equals=1) to All of the Time (equals=5) * Some of the sections ask the patients to answer a question on a scale of Very Dissatisfied (equals=1) to Very Satisfied (equals=4)
Time frame: 6-12 months post-surgery or post-radiation therapy, whichever is later)
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes
Time frame: 6-12 months post-surgery or post-radiation therapy, whichever is later)
Cost-effectiveness of routine CSM in BCS as measured by operative time, specimen processing, and resource usage
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Disease status associated with cancer biomarkers
The investigators plan to assess plasma and serum levels of several candidate biomarkers, including a phosphorylated form of the annexin A2 protein ("P-annexin A2"), in study patients by immunoblotting/ELISA. This biomarker evaluation in the context of disease status will provide new information in the clinical detection and diagnosis of malignancy. Successful validation of these biomarkers may lead to development of novel blood-based cancer diagnostic tests.
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Tumor characteristics associated with cancer biomarkers
The investigators plan to assess plasma and serum levels of several candidate biomarkers, including a phosphorylated form of the annexin A2 protein ("P-annexin A2"), in study patients by immunoblotting/ELISA. This biomarker evaluation in the context of tumor characteristics will provide new information in the clinical detection and diagnosis of malignancy. Successful validation of these biomarkers may lead to development of novel blood-based cancer diagnostic tests.
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
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