MarginProbe® System U.S. Post-Approval Study

Study Overview
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Brief Summary
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The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. *A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

Detailed Description
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This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('SOC + Additional inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm). The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It will be used by the surgeon during lumpectomy procedures only in patients randomized to the Device+SOC arm. Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.

Official Title
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MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Margin Probe
* Other: Control: Additional inspection


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: Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast) Bilateral disease (diagnosed cancer in both breasts) Neo-adjuvant systemic therapy Previous radiation in the operated breast Prior surgery in the same site in the breast Woman histologically diagnosed by an open biopsy procedure Implants in the operated breast Pregnancy Lactation Participating in any other investigational study for either drug or device which could influence collection of valid data under this study Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SOC + Device<br>The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen. | Device: Margin Probe<br>* The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision<br>|
| Other: SOC + Additional Inspection<br>The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen. | Other: Control: Additional inspection<br>* The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy at the margin level | Sensitivity and Specificity at the margin level; | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | 
| Incomplete Surgical Resection (ISR ) | ISR - Positive Margin on the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery, that was not addressed by taking a shaving(s) corresponding to the positive margin(s). | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery | Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | 
| Cosmesis evaluation | Objective evaluation by an evaluator blinded to arm assignment | participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy | 
| Repeat lumpectomy rate | Proportion of patients who underwent a repeat lumpectomy procedure | Participants will be followed for 2-5 weeks (average) | 
| Repeat lumpectomy and mastectomy rate | Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy | Participants will be followed for 2-5 weeks (average) | 
| Diagnostic Accuracy at the Patient Level (ignoring location) | Proportion of patients from whom shavings were taken | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date |