breastscape v1.0

“breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere 3.0 software package. It is intended to be used by trained breast imaging physicians and trained MRI technologists. breastscape V1.0 is an optional PACS software tool that is intended for use with the Olea Sphere V3.0 software package, cleared under K152602. The software accesses image series in DICOM format through Olea Sphere V3.0, which is a software package used to perform image viewing, processing and analysis of medical images.”

“breastscape V1.0 includes a software module (BreastApp) that supports the visualization, analysis, and reporting of lesions measurements and analysis. breastscape V1.0 supports the evaluation of dynamic MR data acquired during contrast administration and the calculation of parameters related to the uptake characteristics. breastscape V1.0 performs other user selected processing functions (such as image subtraction, multiplanar and oblique reformats, 3D renderings). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. breastscape V1.0 can also be used to provide measurements of the segmented tissue volumes (volumes of interest) based on uptake characteristics. These measurements include volume measurement, distances of volumes of interest to anatomical landmarks, 3D longest diameter and 2D long and short axis. breastscape V1.0 includes the option to add annotations based on the fifth edition of the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. breastscape V1.0 includes a software module (BreastLoc) to assists users in planning MR guided breast interventional procedures. Using information from MR images, regarding user-specified target lesion and fiducial location coordinates, the software gives calculation of the targeted region of interest (such as suspected lesion) depth. BreastApp is designed to assist in the visualization, analysis and reporting of Magnetic Resonance Imaging (MRI) breast studies. This module supports the evaluation of dynamic MR breast data acquired during contrast administration (DCE-MRI), and the calculation of parameters related to the lesion uptake characteristics. This module provides semi-automatic segmentation of volumes of interest, distance measurements and lesion volume measurements. BreastApp provides the features below: The computation of image subtractions (subtractions of each time point/phase image of the dynamic series with the 1st time point (baseline) image to highlight tissue with contrast enhancement). The display of time intensity signal curves (kinetics curves) showing tissue contrast enhancement evolution over time. The detection and display of the kinetics curve showing the worst kinetics behavior (most important washout among pixels having peak enhancement superior at 50% enhancing threshold). The computation of semi-quantitative kinetics maps that are derived from the time intensity signal curves and showing uptake characteristics (e.g., Time to Maximum contrast Enhancement, Wash in, Washout, etc.). Automatic detection of breast morphological structures. It includes the automatic detection of nipple position, chest and skin border. The user can further adjust them if needed. Semi-automatic lesion segmentation. It includes: Highlighting tissues showing significant contrast agent uptake based on an uptake threshold. Semi-automatic segmentation of the suspected lesion identified by the user. The user can further adjust the segmentation if needed or even manually segment the suspected lesion. Automatic computation of the suspected lesion 2D/3D diameter and lesion volume. Automatic computation of distances between the suspected lesion and the morphological structures (distances to nipple, chest and skin). The user can further adjust the distances if needed. Reporting of user-selected findings and assessment through a dedicated breast report. It includes the option to add annotations based on the Fifth Edition of American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS®) Breast Imaging Atlas. The software automatically reports the localization of the suspected lesion on a dedicated breast sector map. The position can be further adjusted by the user if needed. Follow-up for multiple (more than two) studies from same patient. It includes tools to enhance the visualization and analysis of patient follow-up studies through the same layout. The BreastLoc module is designed to assist users in planning MR-guided breast interventional procedures. Based on user-specified target lesion and fiducial location coordinates, BreastLoc is used to compute and display the following features: Needle insertion block position within the grid diagram; Needle insertion point activation in the block; Depth of introducer, representing the graduation value where to put the depth stop on the introducer sheath; Needle insertion path display on native images.”