An observational study in Contrast Enhanced Mammography-guided Biopsy, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Parc de Salut Mar · Observational
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.
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.
Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.
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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.
Exclusion Criteria:
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
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.
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.
Time frame: immediately after each CEM-guided biopsy
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: immediately after each CEM-guided biopsy
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar