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Shave Margins in Breast Conservation Therapy (SMART)

Primary Purpose

Breast Cancer, Cancer of Breast, Cancer of the Breast

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Breast-conserving surgery (BCS)
Cavity shave margins (CSM)
BREAST-Q Questionnaire
3-D breast imaging
Indocyanine green
Intraoperative imaging device
Peripheral blood draw
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BCS Arm (breast-conserving surgery - standard of care)

CSM Arm (breast-conserving surgery with cavity shave margins)

Arm Description

Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use). Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.

Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies). Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.

Outcomes

Primary Outcome Measures

Proportion of patients with positive margins on pathological specimen analysis
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)
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results

Secondary Outcome Measures

Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes
Cost-effectiveness of routine CSM in BCS as measured by operative time, specimen processing, and resource usage
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.
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.

Full Information

First Posted
June 1, 2015
Last Updated
June 22, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02462200
Brief Title
Shave Margins in Breast Conservation Therapy
Acronym
SMART
Official Title
Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer of Breast, Cancer of the Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCS Arm (breast-conserving surgery - standard of care)
Arm Type
Active Comparator
Arm Description
Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use). Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.
Arm Title
CSM Arm (breast-conserving surgery with cavity shave margins)
Arm Type
Experimental
Arm Description
Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies). Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.
Intervention Type
Procedure
Intervention Name(s)
Breast-conserving surgery (BCS)
Intervention Type
Procedure
Intervention Name(s)
Cavity shave margins (CSM)
Intervention Type
Behavioral
Intervention Name(s)
BREAST-Q Questionnaire
Intervention Type
Device
Intervention Name(s)
3-D breast imaging
Intervention Description
Using a 3-D breast imaging camera Vectra 3-D XT
Intervention Type
Other
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
ICG
Intervention Type
Device
Intervention Name(s)
Intraoperative imaging device
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Peripheral blood draw
Intervention Description
-Time of surgery if coordinator is available
Primary Outcome Measure Information:
Title
Proportion of patients with positive margins on pathological specimen analysis
Time Frame
Completion of surgery for all enrolled patients (approximately 60 months)
Title
Patient perceptions of the surgery as measured by BREAST-Q questionnaire and novel 3-dimensional breast imaging
Description
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)
Title
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
Time Frame
Completion of surgery for all enrolled patients (approximately 60 months)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Disease status associated with cancer biomarkers
Description
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)
Title
Tumor characteristics associated with cancer biomarkers
Description
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Margenthaler, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Shave Margins in Breast Conservation Therapy

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