MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Study Overview
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Brief Summary
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The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

Detailed Description
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The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a Standard of Care (SOC) Control group and the other arm a Device+SOC group.In the Device +SOC group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Official Title
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MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MarginProbe
* Procedure: Lumpectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women histologically diagnosed with carcinoma of the breast Women with non-palpable malignant lesions, requiring image guided localization. Undergoing lumpectomy (partial mastectomy) procedure. Age 18 years or more Signed ICF Exclusion Criteria: Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) Bilateral disease (diagnosed cancer in both breasts) Neoadjuvant systemic therapy Previous radiation in the operated breast Prior surgical procedure in the same breast Implants in the operated breast Pregnancy Lactation Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SOC<br>Standard of Care arm - standard of care lumpectomy procedure | Procedure: Lumpectomy<br>* Standard of care lumpectomy procedure<br>|
| Experimental: Device + SOC<br>Use of the device in addition to the standard of care lumpectomy procedure. | Device: MarginProbe<br>* Device use to assess margin status of the excised specimen surface.<br>Procedure: Lumpectomy<br>* Standard of care lumpectomy procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. | Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively | two weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDC, DCIS, ILC