Breast Cancer, Cancer of Breast, Cancer of the Breast
Conditions
Brief 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.
Interventions
PROCEDUREBreast-conserving surgery (BCS)
PROCEDURECavity shave margins (CSM)
BEHAVIORALBREAST-Q Questionnaire
DEVICE3-D breast imaging
Using a 3-D breast imaging camera Vectra 3-D XT
OTHERIndocyanine green
DEVICEIntraoperative 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
PROCEDUREPeripheral blood draw
-Time of surgery if coordinator is available
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with positive margins on pathological specimen analysis | 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 | 6-12 months post-surgery or post-radiation therapy, whichever is later) | * 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) |
| Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results | Completion of surgery for all enrolled patients (approximately 60 months) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes | 6-12 months post-surgery or post-radiation therapy, whichever is later) | — |
| Tumor characteristics associated with cancer biomarkers | Completion of surgery for all enrolled patients (approximately 60 months) | 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. |
| Cost-effectiveness of routine CSM in BCS as measured by operative time, specimen processing, and resource usage | Completion of surgery for all enrolled patients (approximately 60 months) | — |
| Disease status associated with cancer biomarkers | Completion of surgery for all enrolled patients (approximately 60 months) | 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. |
Countries
United States
Outcome results
None listed