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Shave Margins in Breast Conservation Therapy (SMART)

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ClinicalTrials.gov Identifier: NCT02462200
Recruitment Status : Terminated (Insufficient funding)
First Posted : June 3, 2015
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer of Breast Cancer of the Breast Procedure: Breast-conserving surgery (BCS) Procedure: Cavity shave margins (CSM) Behavioral: BREAST-Q Questionnaire Device: 3-D breast imaging Other: Indocyanine green Device: Intraoperative imaging device Procedure: Peripheral blood draw Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : November 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BCS Arm (breast-conserving surgery - standard of care)
  • 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.
Procedure: Breast-conserving surgery (BCS)
Behavioral: BREAST-Q Questionnaire
Device: 3-D breast imaging
Using a 3-D breast imaging camera Vectra 3-D XT

Other: Indocyanine green
Other Name: ICG

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

Experimental: CSM Arm (breast-conserving surgery with cavity shave margins)
  • 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.
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
Other Name: ICG

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




Primary Outcome Measures :
  1. Proportion of patients with positive margins on pathological specimen analysis [ Time Frame: Completion of surgery for all enrolled patients (approximately 60 months) ]
  2. Patient perceptions of the surgery as measured by BREAST-Q questionnaire and novel 3-dimensional breast imaging [ Time Frame: 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)

  3. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. Disease status associated with cancer biomarkers [ Time Frame: 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.

  4. Tumor characteristics associated with cancer biomarkers [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462200


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Julie Margenthaler, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02462200    
Other Study ID Numbers: 201506053
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases