Clinical Evaluation of CEM-guided Biopsy

Study Overview
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Brief Summary
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CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as vacuum assisted biopsy, core biopsy, presurgical localization (e.g. hook wire), and fine needle aspirations (FNA). This device cannot be used for reasons other than its intended use. This evaluation is being done to learn more about the CEM-guided biopsy. Clinical user and operational feedback is a central part of the development process for medical devices in which information from real clinical use is required to optimize the device prior to commercial release.

Detailed Description
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Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced Mammography (CEM) images. It is intended to provide guidance for histological purposes such as core or vacuum-assisted biopsies, for pre-surgical localization procedures, or Fine Needle Aspiration (FNA) for cytopathology analysis. The main purpose of this evaluation is to collect feedback to assess image readability and look-and feel, usability, workflow and user preference information from physicians and technologists who use CEM-guided biopsy to perform minimally invasive interventional breast procedures under clinical conditions. All feedbacks are collected by observations, interviews and surveys. The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care. Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.

Official Title
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Clinical Evaluation of CEM-guided Biopsy

Conditions
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Contrast Enhanced Mammography-guided Biopsy

Intervention / Treatment
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* Device: CEM-guided biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care. Are able and willing to comply with study procedures Are able and willing to provide written informed consent to participate Exclusion Criteria: Findings not accessible for stereotactic guidance biopsy Are currently lactating Have breast implants

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult women with indication for a breast biopsy procedure after an abnormal CEM or MRI examination.<br>Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination and no clear ultrasound or mammography correlation. | Device: CEM-guided biopsy<br>* The evaluation population consists of adult women, presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination (with no clear ultrasound or mammography correlation) and considered eligible for this procedure as per standard of care. Eligible subjects undergo the clinically indicated breast biopsy procedure using the Pristina Serena Bright ® CEM-guided biopsy. Region of interest location is determined by using stereotactic pairs of CEM images after injection of iodinated contrast media. All necessary equipment and instrumentation, medications, or other devices required to complete the subject's clinically indicated procedure shall be used and are not expected to be influenced by evaluation participation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image visibility of enhancing finding | To assess the visibility of an index enhancing finding at the point of the CEM-guided biopsy. The enhancement in the biopsy images will be compared to the enhancing lesion initially detected at the diagnostic CEM examination, that led to the prescription of the breast biopsy. It is a subjective and dichotomous measure: visible or not visible. | immediately after each CEM-guided biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology results on biopsy specimen | Pathology results are classified according to the National Health Service Breast Screening Program (NHSBSP) classification for breast biopsies in B1 (normal tissue), B2 (benign lesion), B3 (lesion of uncertain malignant potential), B4 (suspicious), B5 (malignant). | up to 3 weeks | 
| Upgrade rate to malignancy of biopsied lesions that underwent surgical or percutaneous intervention | To evaluate the upgrade rate to malignancy of lesions that were further assessed with surgical or percutaneous intervention. The term upgrade to malignancy applies for lesions that were diagnosed as high-risk lesions at biopsy (B3), but with final pathology at excision changed to malignancy (in situ or invasive), as well as for in situ lesions at biopsy upstaged to invasive cancer at surgery. | an average of 3 months | 
| Number of participants with CEM-guided biopsy minor complications. | To register the number of participants that underwent minor complications related to the CEM-guided procedure, such as presence of immediate hematoma in biopsy bed or experienced vasovagal reactions during or inmediately after the procedure. This information will be registered in three categories: hematoma, vasovagal reaction or no complications. | immediately after each CEM-guided biopsy | 
| Biopsy needle approach | To register the needle entry to the breast in order to access the intended lesion during the biopsy procedure as it was through a vertical or horizontal approach. It is a dichotomous measure: vertical or horizontal. | immediately after each CEM-guided biopsy | 
| Total time per procedure | To register the time spent during the biopsy procedure. The time will be considered since the intravenous contrast administration until the breast decompression, immediately after clip marker deployment. It is a numeric variable and will be measured in minutes and evaluated as a median interquartile range. | immediately after each CEM-guided biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Enhanced Mammography, breast cancer, interventional breast procedures