1. Renate Höcker, Antje Schroeder, Siemens Healthcare IHE Radiology – DBT Supplement Supplement Development Kick-Off

2. Introduction Huge success of MAMMO Image Profile 21 Modalities, 44 Image Manager/Archives, 30 Image Displays in Product Registry Tomosynthesis shares many features with 2D Mammography but has additional specific requirements, which are needed for interoperability Use cases Review DBT Images (simple Usecase) In repeated screening mammography current and prior Mammograms/DBT images are reviewed prior exam was Tomosynthesis prior exam was ordinary digital mammography (FFDM) only current or prior Tomosynthesis also includes FFDM ("combination study") current or prior Tomosynthesis also includes synthetic (MIP) view

3. Review DBT Images (simple use case, review happens later) Acquisition Modality creates DBT (Slices, Slabs, Synthectic images?) Objects (at least (?) 2 Objects one for each breast, possibly more) Images are stored in an archive Later on multiple screening cases are retrieved for review consecutively Review of DBT objects (expected review time = 30-90 sec per case) It is expected to be able to scroll through all images in 30 sec Generate report

4. Review DBT Images (review happens instantaneously) Acquisition Modality creates DBT (Slices, Slabs, Synthectic images?) Objects (at least (?) 2 Objects one for each breast, possibly more) 2-3 minutes after acquisition the complete exam needs to be available at review workstation Average object size 1GB Review of DBT objects (expected review time = 30-90 sec per case) –It is expected to be able to scroll through all images in 30 sec –Generate report Images are stored to the archive from the Modality

5. Review DBT Images together with 2D Assumption: Basic workflow is the same for 2D Mammograms and synthetic images, there will just be some labeling. Assumption: this is applicable to both wet reading and batch reading Modality creates 2 DBT objects and up to four mammograms Images get stored at the archive Images get retrieved at workstation for review How are those reviewed, simultaneously, one after the other? Is there a use case/requirement for simultaneous review. Does it need to be configurable? 2D images are required to be displayed!

6. Review DBT Images together with 2D and synthetic 2D images Is this a typical use case or are they used for regulatory approval purposes? Is this useful during the transition period until each physician is comfortable using synthetic images?

7. All of the above with 4 DBT objects – (2 or more views/breast) (no comparison) Same discussed in previous scenarios

8. Comparison with priors Current DBT with prior 2D mammograms Is just the navigation through the volume, that is additionally needed? What is currently done when comparing 3D to 2D Current DBT comparison with prior DBT object Scrolling according to location 2D images have CAD marks

9. Scope In addition to functionality defined in MAMMO Creation and storage of digital breast Tomosynthesis image Viewing of breast Tomosynthesis Images Simultaneous review of Tomosynthesis images and 2D mammograms

10. In scope? Out of scope? Storage/Review of Projection X-Ray objects ? What are requirements / use cases that mandate support for this object Currently no use case is defined, therefore out of scope Support of CAD on Tomosynthesis images? Currently open work item for WG15, therefore out of scope Is lossless compression needed? In scope for now. Storage: Should it be optional on the Modality to send and Image Display to retrieve and Should it be mandatory on the Image Manager to support receiving and retrieval Retrieval : Does Image Display need to support retrieving compressed images Must the Image Manager be able to (un)compress, if requested by the Image Display

11. In scope? Out of scope? Do we need to specify DICOM concatenation? Answer is no, since complete study is needed for review Synthetic Images? Synthetic images are treated as normal mammograms (besides annotation) pending clinical discussion Do we need an evidence Creator to create synthetic images? Partial View? Do whatever what MAMMO image did Do we need Key Objects to mark key images/frames Pending clinical input If we need to support Key Images are changes to Key Image Note profile needed. Is this an option to MAMMO or a new profile? Antje to review current Template for content profile

12. Clinical Questions Are there any Use Cases missing? Is support of projection images for presentation necessary? We did not find any use cases mandating them. If so, how are those clinically used? Is there a use case for simultaneously reviewing all type of images (FFDM, Tomosynthesis, Projection images, synthetic Images)? If yes, how should all these objects be displayed simultaneously Synthetic images: Do we need to distinguish between 2D images and synthetic images? Is there difference in reviewing 2D images vs synthetic image? Is there a clinical requirement for 2D CAD on synthetic images

13. Clinical Questions Would you like to flag of Key Images/frames? Are partial views used/relevant in Tomosynthesis How should orientation information be displayed Do contrast adjustments need to be performed on a per image basis or for the complete object? What are synthetic images from a clinical point of view? Are 3D visualization of DBT object necessary Are there any regulatory/MQSA relevant requirements that we need to take into account Are there use cases for printing DBT images?

14. DBT Supplement Topic to be addressed in a DBT Supplement: Volume 1 –If option: update Option Table for relevant actors (MOD, IM/IA, ID) –Add use case for Tomosynthesis review including the following scenarios Breast Tomosynthesis Images prior exam was Tomosynthesis prior exam was ordinary digital mammography (FFDM) only current or prior Tomosynthesis also includes FFDM ("combination study") current or prior Tomosynthesis also includes synthetic (MIP) view

15. DBT Supplement Volume 2 Creation and Storage of relevant objects (Rad-4) Define additional SOP Classes that are needed Define restrictions on DICOM Header for each additionally supported SOP Class –Information that is needed in order to properly hang and display images »Patient Orientation/Plane Position/View information/… –Information that is needed for annotation »Patient Information/Acquisition Parameters/…

16. DBT Supplement Volume 2 Retrieval and display of relevant objects (Rad-16) Display of Breast Tomosynthesis Images Describe simultaneous display of involved objects –FFDM images/Tomosynthesis objects/Projection images/synthetic images »Which objects need to be displayed simultaneously (screen real-estate)? –Describe hanging and ‘proper’ orientation of displayed objects –Describe how different sizing options (image size, same size, true size and actual pixel viewing) effect display of Tomosynthesis objects (in simultaneous as well as full size display)

17. DBT Supplement Retrieval and display of relevant objects (Rad-16) - continued Describe contrast adjustments (in simultaneous as well as full size display) –Do we need to say something toggling between different LUTs when displaying multiple object types? Scrolling through the Tomosynthesis object –User driven / automatic –Synchronized scrolling of different views –Scrolling performance –Scrolling direction

18. DBT Supplement Retrieval and display of relevant objects (Rad-16) – continued Describe annotations –Patient Information –Acquisition parameters (per supported object type) including e.g. acquisition angle, dose –View information –Orientation in volume »which is the detector side, where in the volume is the current frame located »Frame numbers »Identify synthetic images

19. DBT Supplement Depending on the decision on CAD additional changes to the following transactions are needed: Storage of Evidence Objects (Rad-43) –How to record findings on DBT images »Does current TID 4000 work or are there any changes necessary (how to reference coordinates)? Retrieval and display of CAD marks (Rad-16) Effects on MAWF and SMI still need to be investigated