Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe

Study Overview
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Brief Summary
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The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple studies have demonstrated the association between positive lumpectomy margins and an increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation. Studies report 20-40% of lumpectomy procedures result in one or more involved (positive) surgical margins, leading to the need for further surgery, emotional distress, poorer cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative margin assessment techniques include specimen Xray, gross pathology, frozen section, and touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative assessment of the presence of tumor at the lumpectomy margin. In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.

Detailed Description
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In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures. Aims of the study: Primary objectives 1. Determine positive margin rate following lumpectomy Secondary objectives Determine accuracy of intraoperative margin assessment with use of MarginProbe plus standard of care (gross pathologic examination and/or intraoperative specimen Xray) versus standard of care (gross pathologic examination and/or intraoperative specimen Xray) alone. Determine impact of MarginProbe on total tissue volume removed Determine the impact of MarginProbe on the need for additional surgical procedures.

Official Title
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A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MarginProbe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Subjects able to read and understand the informed consent Exclusion Criteria: 1. Subjects unable to read or understand the informed consent.
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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MarginProbe<br>Single arm study - MarginProbe in addition to standard procedure | Device: MarginProbe<br>* Intraoperative MarginProbe use as adjunct to standard practice MarginProbe will be used on the lumpectomy specimen within 20 minutes of excision, prior to specimen Xray or gross pathology evaluation. This may take up to 5 minutes. MarginProbe will indicate a positive or negative reading for each of the 6 circumferential margins, and the results will be recorded. Any margins determined by to < 5-10 mm by specimen Xray or gross pathology examination will be re-excised. In addition, any additional margins not already identified as < 5-10 mm, but identified as positive by MarginProbe will be re-excised where feasible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with histologically positive surgical margins |  | 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who undergo a second surgery after initial lumpectomy. |  | 2 weeks after surgery | 
| False positive and false negative rate of Intraop MarginProbe results compared to histologic evaluation |  | 2 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumpectomy margins