Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment

Study Overview
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Brief Summary
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This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.

Official Title
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Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)

Conditions
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Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery

Intervention / Treatment
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* Device: Histolog Scanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female Subject ≥18 years old. Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma. Subject is able to read, understand and sign the informed consent. Exclusion Criteria: Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery. Subject with previous radiotherapy of the ipsilateral breast. Subject with multicentric/multilateral breast cancer. Subject with planned mastectomy, tumor-adapted breast reduction. Subject with pre-surgical/ preoperative neo-adjuvant treatment. Subject is pregnant/ lactating. Participation in any other clinical study that would affect data acquisition.

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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prospective<br>50 prospective subjects | Device: Histolog Scanner<br>* The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.<br>|
| No Intervention: Historical<br>40 historical subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation Rate | Differences in the rate of reoperation due to cancer positive margins | 2-30 days post Breast Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance] | To observe real life clinical performance of the HLS and accessories when used intraoperatively | 0-30 days post Breast Surgery | 
| System Usability Scale (SUS) of the IVD device and accessories [Usability] | To survey usability of the HLS and accessories when used intraoperatively | Only during the time of the breast surgery | 
| Change in hospital cost with or without IVD device and accessories [Economic Impact] | To evaluate the economic impact for the hospital/payer of the reoperation rate | 30 days post surgery date | 
| Incidence of adverse device effects [Safety] | Incidence of adverse device effects during surgery | Only during the time of the breast surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reoperation Rate, Breast Conserving Surgery, Confocal laser scanning microscope, Confocal microscopy