Shave Margins in Breast Conservation Therapy

Breast Cancer Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02462200
• Other study ID #: 201506053
• Status: Terminated
• Phase: Phase 2
• Start date: June 13, 2016
• Est. completion date: November 27, 2019

Study information

• Verified date: June 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Breast-conserving surgery (BCS)

• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with positive margins on pathological specimen analysis		Completion of surgery for all enrolled patients (approximately 60 months)
Primary	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)	6-12 months post-surgery or post-radiation therapy, whichever is later)
Primary	Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results		Completion of surgery for all enrolled patients (approximately 60 months)
Secondary	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)
Secondary	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)
Secondary	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.	Completion of surgery for all enrolled patients (approximately 60 months)
Secondary	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.	Completion of surgery for all enrolled patients (approximately 60 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine