MAMMOMAT B.brilliant - Insight BD (USA)

MAMMOMAT B.brilliant Insight BD Job Aid Introduction Insight Breast Density (Insight BD, INBD) is an option and therefore needs a license. Be aware that the United States federal law restricts the sale of this device by or on the order of a physician. By using raw image data, Insight BD provides automated breast density measurement and refers to the amount of glandular tissue in the breast. Higher breast density decreases the sensitivity of mammography because masses might be hidden in the dense tissue areas. Insight BD calculation is available for MLO and CC views acquired in Standard 2D, Prime, Tomo, Prime + Tomo, and 2D + Tomo acquisition mode. It is not available for other projection views or acquisition modes (for example Implant acquisition mode or ML view). Advantages of automated breast density measurement are: • The objective, consistent and independent assessment of density. • The results of density measurements are available at the acquisition workstation, in addi- tion to the radiologist's workstation, allowing optimization of the clinical workflow. • The combination of percentage volumetric breast density plus the masking risk assess- ment provides a more comprehensive characterization of the breast density. Area-based breast density measurement Area-based methods quantify the area of fibroglandular (dense) tissue in a mammogram as a fraction of the entire two-dimensional breast area. Examples are the visual analog scale in which radiologists estimate the percentage of mammographic density between 0-100% and semiauto- mated interactive thresholding techniques. The disadvantage is that area-based assessment is not truly objective. The result depends on the (subjective) threshold in pixel gray value that distin- guishes fibroglandular from fatty breast tissue. In addition, area-based methods do not take tissue overlap into account. Volume-based breast density measurement The volumetric breast density method calculates the volume fraction of fibroglandular tissue in relation to the entire breast volume (in cm3), based on the known compressed breast thickness and the number of pixels indicating breast tissue. Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Master Template Effective Date: 21 Apr 2023 | HILS 2224 Job Aid Effective Date: 6 Sep 2024 | QR700012902 Healthineers Job Aid | Insight BD Effective Date: 6 Sep 2024 | QR700012902 Intended use Insight BD is a software application for volumetric density assessment from digital x-ray images of the breast. The aim is to aid healthcare professionals in the assessment of breast tissue composi- tion. Please note: • Insight BD is not a diagnostic aid. Use it only as adjunctive information. • Breast density is calculated based on prior and current images. • Implants cause inaccurate breast density index. Please note: Insight BD may not work reliably in the following cases: • Breast is not fully visible in one image (for example cleavage, magnification, or mosaic im- age) • When a foreign object (for example implant, guidance wire, pacemaker, clips) appears inside the breast • If the breasts are not evenly compressed • Nonfemale breast • Breast-feeding women • Female breast after mastectomy • Mastectomy samples In these cases, consider visual evaluation instead. Insight BD examination Perform Insight BD examinations at the workstation with preset examination parameters. Check the values on the 2D FFDM image, the first view, on all tomosynthesis slices as well as on the In- sight 2D image. Prepare the system and register the patient, the breast density values display at the workstation via View > INBD. This shows the calculated values of the breast density per image and the breast density per breast. Activate the first projection view to start the procedure with 2D images. 1. Acquisition of the first image, for example R-CC The acquisition workstation (AWS) processes the image and calculates the breast density values for the image automatically. It saves the breast density values and the image and displays the values of the breast density calculation as image text. 2. Acquire subsequent images The AWS processes one image after the other and automatically calculates the breast den- sity values per image. It saves the result in a DICOM SR object. If configured, you can find the breast density grade for this image in the image comment (DICOM Tag 0020,4000). The AWS automatically calculates the breast density values of a patient’s breasts, after ac- quiring the CC and MLO views of the same breast. The AWS saves the calculated values. Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Job Aid Effective Date: 6 Sep 2024 | QR700012902 Healthineers Page 2 of 7 Job Aid | Insight BD Effective Date: 6 Sep 2024 | QR700012902 Breast density values per breast (CC & MLO) and for the patient, are stored in the DICOM SR report. Only the values per image are stored as image text. Examination settings Define the settings for the Insight BD examination in the subtask cards of the Examination task card. Select the procedure required from the Procedure selection list. The projection sequence preset for the procedure is displayed in the PV sequence list. 1. Open the Acquisition subtask card to check the corresponding exposure type and recon- struction parameter group for the selected procedure. Open patient Acquisition Acquisition mode: Standard 2D IPPG: F1_Gen1 INBD n.a Skip InExam Transfer Post processing Close patient 2. The INBD button only appears if a license is available and the display is activated. When you click on the button, the Insight BD popup appears, including the settings from the Ser- vice menu. Insight BD Patient Name: Testimages Clinical Patient ID: 0115 Density grade for Patient Study date: 02/21/20 Right Left Volume of fibroglandular (cm3) 44.9 43.7 a Volume of Breast (cm3] 1177.3 1199.2 Volumetric Breast Density (%) 3.8 3.6 Density grade Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Job Aid Effective Date: 6 Sep 2024 | QR700012902 Healthineers Page 3 of 7 Job Aid | Insight BD Effective Date: 6 Sep 2024 | QR700012902 Values per breast laterality (right and left breast): • Volume of fibroglandular tissue (cm³): The estimation of the volume of nonfatty tissue in the breast in cubic centimeters (cm³). • Volume of Breast (cm³): The estimation of the total breast volume in cubic centi- meters (cm³). • Volumetric Breast Density (%): The ratio of the fibroglandular tissue volume to the breast volume in percent. • Density grade: Breast density grade per breast (laterality) (a-d), mean value or maximum value (configurable in the service menu). Value per patient: • Density grade for patient (a-d), mean value or maximum value (configurable in the service menu). Please note: The Volume of fibroglandular tissue values displayed in the Insight BD dialog win- dow may deviate from the ones in the image. The image always shows the Volume of fibroglan- dular tissue values of the respective image. The Insight BD dialog window shows the calculated values of all previously available right and/or left exposures. i Insight BD calculates the volumetric breast density and computes the true volume of the fibro- glandular tissue in the breast. Additionally, it takes the masking risk into account. The resulting percentage values are not comparable to the percentage scale of the ACR BI-RADS (from the 4th edition of the area-based ACR BI-RADS classification). The typical values for volumetric breast den- sity have a range from 0 to 30%. In exceptionally dense breasts, values up to 60% breast density may occur. Displaying/hiding Insight BD values Select View > INBD to show the breast density values in the examination image text. To hide them, deselect this view. Rejecting Insight BD values • Manually: o If you take the same view twice (for example R-CC, R-CC), you should manually re- ject one view for BDI calculation. Right-click the image and select Reject InBD Val- ues. o The breast density index will no longer be visible in the examination image and is excluded from the calculation of the breast and patient values. The text BDI was rejected by user will appear on the image. Once the InBD values are rejected, they can be displayed again by reprocessing the image. Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Job Aid Effective Date: 6 Sep 2024 | QR700012902 Healthineers Page 4 of 7 Job Aid | Insight BD Effective Date: 6 Sep 2024 | QR700012902 • Automatically: o You cannot perform a breast density analysis reliably when:  The breast thickness is too thin (body part thickness < 20 mm).  The breast area is too small (< 36 cm2; this is equivalent to 5% of the area of a compression paddle 24 cm x 30 cm). o The information BDI was rejected automatically is then added to the image com- ment. Uncertainty indicator If the breast density index (CC and MLO view; laterality taken; same breast; same examination) differs by more than one category, the AWS indicates the uncertainty of the derived values on the display. Click on the INBD button to open the Insight BD dialog box. The uncertainty indicator is displayed within the Insight BD dialog box below the density grades for each breast. Insight BD Patient Name: BDI Uncertain Patient ID: 20.01.21-16:27:47-STD-1.3.12.2.1107.5.12.7.305 Density grade for Study date: 01/21/20 Patient Right Left Density grade C a (") c (*) uncertain value Insight BD | Settings Insight BD configuration Only local application specialists can configure Insight Note: changes will take effect after restart of the workstation. BD on the service platform. The following parameters Breast composition categories : can be modified according to local requirements: d. D 4.3 % 4.3 8.1 % Breast composition categories: Siemens Healthineers C: 8.1 17 % breast composition category that correlates with ACR BI- 17 100 % "Upper limits are inclusive, which means the upper limit belongs to the given rangel RADS 5th edition visual assessments done by the radiolo- gist. Activate Insight BD: M a: Almost entirely fatty Values per patient: Average . Highest b: Scattered fibroglandular density Value per breast laterality: O Average Highest c: Heterogeneously dense Display for user: d: Extremely dense Volume of Fibroglandular tissue: Breast Volume: Volumetric Breast Density: Store category in Image Comment: Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Job Aid Effective Date: 6 Sep 2024 | QR700012902 Healthineers Page 5 of 7 Job Aid | Insight BD Effective Date: 6 Sep 2024 | QR700012902 Values per patient: • Average: Uses the average of the results from the right and left breast to generate a cate- gory for the patient (corresponding to ACR BI-RADS 4th edition). • Highest: Uses the maximum value of the results from the right and left breast to generate a category for the patient (corresponding to ACR BI-RADS 5th edition). This may increase the overall density grade compared to using averaging. Values per breast laterality: • Average: Uses the average value of the R-CC and R-MLO projection views. • Highest: Uses the maximum value from the R-CC and R-MLO projection views (default). Insight BD | Configuration (The following steps will be configured by Siemens Healthineers) 1. Select Activate Insight BD to activate the Insight BD calculation for all following examina- tions. 2. Enter the percentage limits for the Breast composition categories. 3. Choose the type of calculation for Values per patient and Values per breast laterality. 4. Select Volume of Fibroglandular tissue, Breast Volume and/or Volumetric Breast Den- sity to display the related values in the Insight BD dialog window. • Volume of Fibroglandular tissue: Computed as the mean or maximum value of all ap- plicable CC and MLO views with the same breast laterality available in this study. • Breast Volume: Computed mean or maximum value of all applicable CC and MLO views with the same breast laterality available in this study. • Volumetric Breast Density: Volume of fibroglandular tissue related to the breast vol- ume per breast. • Density Grade: Computed as mean or maximum grade from all applicable CC and MLO views from the same breast laterality available in this study. The density grade is deter- mined from the volumetric breast density. 5. Select Store in Image Comment to store the density grade of the image to the defined DICOM Tag. Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Job Aid Effective Date: 6 Sep 2024 | QR700012902 Healthineers Page 6 of 7 Job Aid | Insight BD Effective Date: 6 Sep 2024 | QR700012902 Please note this learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. 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