Digital Imaging and Communications in Medicine (DICOM) Supplement 50: Mammography Computer-Aided Detection SR SOP Class

Transcription

1 Digital Imaging and Communications in Medicine (DICOM) Supplement 50: Mammography Computer-Aided Detection SR SOP Class Status: Draft 19 June 28, 2000 (Public Comment) DICOM Standards Committee 1300 N. 17 th Street Rosslyn, Virginia USA

2 Page 2 Table of Contents Table of Contents... 2 Foreword 5 Scope and Field of Application... 6 OPEN ISSUES... 6 Part 3, Annex A Addendum... 8 A.X STRUCTURED REPORT DOCUMENT INFORMATION OBJECT DEFINITIONS... 8 A.X.1 CAD SR Information Object Definition... 8 A.X.1.1 Mammography CAD SR Information Object Description... 8 A.X.1.2 Mammography CAD SR IOD Entity-Relationship Model... 8 A.X.1.3 Mammography CAD SR IOD Module Table... 8 A.X Mammography CAD SR IOD Content Constraints... 9 A.X Template Identification... 9 A.X Value Type... 9 A.X Relationship Constraints... 9 Part 3, Annex X Addendum...11 ANNEX X (INFORMATIVE)...11 X.1 Mammography CAD SR Content Tree Structure...11 X.2 Mammography CAD SR Observation Context Encoding...13 X.3 Mammography CAD SR Examples...14 Example 1: Calcification and Mass Detection with No Findings...14 Example 2: Calcification and Mass Detection with Findings...15 Example 3: Calcification and Mass Detection, Temporal Differencing with Findings...20 Part 4 Addendum...30 B.5 STANDARD SOP CLASSES...30 B Structured Reporting Storage SOP Classes...30 I.4 MEDIA STANDARD STORAGE SOP CLASSES...30 O.2.x Mammography CAD SR SOP Class...30 O.4.1.x Mammography CAD SR SOP Class...30 O.4.2.x Mammography CAD SR SOP Class...31 Part 6 Addendum...32 ANNEX A (NORMATIVE): REGISTRY OF DICOM UNIQUE IDENTIFIERS (UID)...32 Part 16 Addendum...33 ANNEX X: MAMMOGRAPHY CAD SR IOD TEMPLATES...33 TID nnn1 Mammography CAD SR IOD Document Root Template...34 Content Item Descriptions...35 TID nnn2 Mammography CAD SR IOD Overall Impression/Recommendation Template Content Item Descriptions...35 TID nnn3 Mammography CAD SR IOD Impression/Recommendation Body Template Content Item Descriptions...36 TID nnn4 Mammography CAD SR IOD Individual Impression/Recommendation Template Content Item Descriptions...37 TID nnn5 Mammography CAD SR IOD Composite Feature Template...38 TID nnn6 Mammography CAD SR IOD Composite Feature Body Template...39 Content Item Descriptions...40 TID nnn9 Mammography CAD SR IOD Single Image Finding Template...41 Content Item Descriptions...42 TID nnn10 Mammography CAD SR IOD Single Image Finding Generic Template...42 Content Item Descriptions...42 TID nnn11 Mammography CAD SR IOD Single Image Finding Breast Composition Template. 43 Content Item Descriptions...43

3 Page 3 TID nnn12 Mammography CAD SR IOD Single Image Finding Breast Geometry Template Content Item Descriptions...43 TID nnn13.1 Mammography CAD SR IOD Single Image Finding Individual Calcification Template 44 TID nnn13.2 Mammography CAD SR IOD Single Image Finding Calcification Cluster Template44 TID nnn14 Mammography CAD SR IOD Single Image Finding Density Template...45 TID nnn15 Mammography CAD SR IOD Single Image Finding Nipple Template...45 Content Item Descriptions...45 TID nnn16 Mammography CAD SR IOD Single Image Finding Non-Lesion Template TID nnn17 Mammography CAD SR IOD Single Image Finding Selected Region Template TID nnn18 Mammography CAD SR IOD Single Image Finding Image Quality Template Content Item Descriptions...47 TID nnn19.1 Mammography CAD SR IOD Detections Performed Template...48 TID nnn19.2 Mammography CAD SR IOD Analyses Performed Template...48 TID nnn20 Mammography CAD SR IOD Detection Performed Template...48 Content Item Descriptions...49 TID nnn21 Mammography CAD SR IOD Analysis Performed Template...50 Content Item Descriptions...50 TID nnn21.5 Mammography CAD SR IOD Algorithm Identification Template...50 TID nnn22 Mammography CAD SR IOD Image Library Entry Template...51 Content Item Descriptions...51 TID nnn23.1 Mammography CAD SR IOD Linear Measurement Template...52 Content Item Descriptions...52 TID nnn23.2 Mammography CAD SR IOD Area Measurement Template...52 Content Item Descriptions...52 TID nnn23.3 Mammography CAD SR IOD Volume Measurement Template...53 Content Item Descriptions...53 TID nnn25 Mammography CAD SR IOD Geometry Template...53 ANNEX Y: MAMMOGRAPHY CAD SR IOD ADOPTIVE TERMINOLOGY AND NOMENCLATURE 54 BI-RADS Terminology and Nomenclature:...54 MQCM 1999 Terminology and Nomenclature...54 MQSA Terminology and Nomenclature...54 ANNEX Z: MAMMOGRAPHY CAD SR IOD MICROGLOSSARY...55 CONTEXT GROUP Overall Breast Composition...55 CONTEXT GROUP Change Since Last Mammogram or Prior Surgery...55 CONTEXT GROUP Characteristics of Shape...56 CONTEXT GROUP Characteristics of Margin...56 CONTEXT GROUP Density Modifier...56 CONTEXT GROUP Calcification Types...56 CONTEXT GROUP Calcification Distribution Modifier...57 CONTEXT GROUP Single Image Finding...57 CONTEXT GROUP Composite Feature...58 CONTEXT GROUP Clockface Location...58 CONTEXT GROUP Quadrant Location...59 CONTEXT GROUP Side...59 CONTEXT GROUP Depth...59 CONTEXT GROUP Assessment...59 CONTEXT GROUP Recommended Follow-up...60 CONTEXT GROUP Pathology Codes...60 CONTEXT GROUP xxxx1 Intended Use of CAD Output...63 CONTEXT GROUP xxxx2 Composite Feature Relations...63 CONTEXT GROUP xxxx3 Scope of Feature...64 CONTEXT GROUP xxxx4 Quantitative Temporal Difference Type...64 CONTEXT GROUP xxxx4.1 Qualitative Temporal Difference Type...64 CONTEXT GROUP xxxx5 Nipple Status...64 CONTEXT GROUP xxxx6 Non-Lesion Object Type...65 CONTEXT GROUP xxxx7 Image Quality Finding...65

4 Page 4 CONTEXT GROUP xxxx8 Status of Results...67 CONTEXT GROUP xxxx9 Types of CAD Analysis Performed...67 CONTEXT GROUP xxx10 Types of Image Quality Assessment...68 CONTEXT GROUP xxx11 Types of Quality Control Standard...68 CONTEXT GROUP xxx12 Units of Follow-up Interval...68 CONTEXT GROUP xxx13 Units of Linear Measurement...68 CONTEXT GROUP xxx14 Units of Area Measurement...69 CONTEXT GROUP xxx15 Units of Volume Measurement...69 CONTEXT GROUP xxx16 Linear Measurements...69 CONTEXT GROUP xxx17 Area Measurements...70 CONTEXT GROUP xxx18 Volume Measurements...70 CONTEXT GROUP xxx19 Units of 1D, 2D and 3D Measurement...70 CONTEXT GROUP xxx20 CAD Processing Summary...70

5 Page 5 Foreword This supplement to the DICOM standard introduces the DICOM format for the results of computer-aided detection (CAD) of potential malignancies in mammograms. The supplement provides the means for encoding a CAD system s mammographic analysis. This includes such basic information as: Lesion type, e.g., density, microcalcification cluster, architectural distortion Bounding regions of lesions, as given by a rectangle, ellipse or polyline Correlation between lesions detected in different views of a mammogram The supplement also defines the DICOM format for advanced mammographic findings more commonly associated with computer-aided diagnosis (CAD x ). Examples of such findings include the morphology of lesions, descriptions of the breast architecture, image quality metrics and overall impressions of and recommendations for the mammogram. The use of CAD x information is optional, so makers of systems that produce only CAD results can still use the format described herein. This draft Supplement to the DICOM Standard was developed according to DICOM Committee Procedures. The DICOM Standard is developed in liaison with other Standards Organizations including HL7, CEN/TC 251 in Europe and MEDIS-DC, JAMI, and JIRA in Japan, with review by other organizations. The DICOM Standard is structured as a multi-part document using the guidelines established in the following document: - ISO/IEC Directives, 1989 Part 3 - Drafting and Presentation of International Standards. This document is a Supplement to the DICOM Standard. It is an extension to PS 3.3, PS 3.4 and 3.6 of the published DICOM Standard which consists of the following parts: PS Introduction and Overview PS Conformance PS Information Object Definitions PS Service Class Specifications PS Data Structures and Encoding PS Data Dictionary PS Message Exchange PS Network Communication Support for Message Exchange PS Point-to-Point Communication Support for Message Exchange PS Media Storage and File Format PS Media Storage Application Profiles PS Media Formats and Physical Media PS Print Management - Point-to-point Communication Support PS Grayscale Standard Display Function PS Security Profiles These Parts are independent but related documents.

6 Page 6 Scope and Field of Application This supplement to the DICOM standard only defines how the results of a computer s mammographic analysis (the CAD output) should be encoded. It does not define or describe inputs to the CAD system other than use of CAD output (e.g. prior year s report) as input to subsequent temporal analyses; nor does it treat CAD output for studies other than mammograms. Note that the CAD input may be comprised of digitized or digitally acquired X-ray images, ultrasound or other germane mammographic images. Some of the information described is beyond that which current CAD systems can produce. However, the DICOM committee includes it because it is expected to become relevant during the lifetime of the supplement. The CAD output is in the form of a DICOM Structured Report. The report can be used on its own, for example for displaying the detected lesions on a monitor or printer. It can be used within a larger Structured Report document, e.g., as part of a comprehensive mammogram screening report. It can even be used as input to a CAD system, for example to provide information on CAD detections in prior years mammograms. In all cases, the output is a Structured Report (SR), so readers should become familiar with Comprehensive SR IOD and corresponding SOP class. In addition, provision has been made to allow description of the CAD output using BI-RADS terminology and nomenclature (see Annex Y, Z). International organizations are being encouraged to contribute additional terminology and nomenclature. This document specifies the Mammography CAD SR IOD and the corresponding CAD Storage SOP class. Since this supplement proposes changes to existing parts of DICOM, the reader should have a working understanding of the Standard. The Mammography CAD SR IOD object is designed to allow a sparsely populated content tree, depending on the capabilities of the CAD system producing this object. Since the content tree defined in this document can incorporate many of the same impressions a human observer would make (at least for a period of time) it is not a requirement that CAD systems be able to fully encode all elements in the content tree templates. Instead, CAD systems may populate optional elements as they see fit, to meet the requirements of the market; different CAD systems may populate the content tree differently. The content tree sparseness does put more burden onto devices parsing and interpreting the content tree. Interoperability needs may force parsers to handle a broad array of sparsely populated trees. OPEN ISSUES 1. What will the Supplement 53 Revision 18 Observation Context, Quoted-Document (currently TID 25) and Quoted Document Root Context (currently TID 59) and their subordinate templates finally look like? Are these sufficient for our needs? 2. International language translation: The CAD SR templates must have the flexibility to allow alternate language translations for. Determine how Supplement 53, Revision 18,TID 90 Language Translation of code meaning field should be incorporated into this document, and whether that is sufficient. Determine whether this affects the use of the CAD SR templates as Enumerated versus Defined. 3. Is Rendering Intent in conflict with the guideline that an SR SCP will faithfully render the full meaning of the document? See Supplement 23, Final Text, Part 4, Annex O. 4. How can a text-only Mammo report be generated from the same CAD SR that includes SCOORD if the SCOORD is in a Required for Presentation sub-tree? 5. Can a Mammography CAD SR SCP device, depending on its capability, opt (when available) to render certain locale information in textual form (e.g. There is mass in the upper-outer quadrant or at the 11 o clock position ) rather than at location (569,2334) when it is the most appropriate means of rendering the SR document to the clinician?

7 Page 7 6. Review sections added to Part 4, Annex O, to explain the intended Behavior of an SCU and Behavior of an SCP for the Mammography CAD SR SOP Class. See also Supplement 23, Final Text, Annex O: Structured Reporting Storage SOP Classes. 7. All of the Concept Names and Context Groups defined in this Supplement must be assigned Code Values. The ACR is evaluating potential options for the encoding of the BI-RADS TM terminology. 8. Is there additional information we need to include about BI-RADS TM? Such as its use as defined terms vs. enumerated values, and allowing extensions for international use? 9. Review ACR legal statements 10. In TID nnn19.1 and TID nnn19.2, the Value Type of Successful Detections, Failed Detections, Successful Analyses and Failed Analyses was changed from CONTAINER to TEXT with a NULL value in order to maintain the rule from the Comprehensive SR IOD that Content Items with a Value Type of CONTAINER shall only be the target of relationshis other than CONTAINS, if this relationship is conveyed by-reference. See Supplement 23, Final Text, A If a content item has Required Type U and its target content item(s) have Required Type M then the target content item is only required if the source content item exists. The explanation of Required Type in Supplement 53 should clarify this.

8 Page 8 Part 3, Annex A Addendum Add the following to PS 3.3 Annex A Update the Composite Module Table to include Mammography CAD SR IOD and Modules IODs Modules Patient Specimen Identification General Study Patient Study SR Document Series General Equipment SR Document General SR Document Content SOP Common Mammography CAD SR M C M U M M M M M A.X STRUCTURED REPORT DOCUMENT INFORMATION OBJECT DEFINITIONS A.X.1 CAD SR Information Object Definition A.X.1.1 Mammography CAD SR Information Object Description The Mammography CAD SR IOD is a constrained Comprehensive SR IOD. The content may include textual and a variety of coded information, numeric measurement values, references to the SOP Instances and spatial regions of interest within such SOP Instances. Relationships by-reference are enabled between Content Items. A.X.1.2 Mammography CAD SR IOD Entity-Relationship Model The E-R Model in Section A.1.2 of this Part applies to the Mammography CAD SR IOD. The Frame of Reference IE, and the IEs at the level of the Image IE in Section A.1.2 are not components of the Mammography CAD SR IOD. Table A.X.1-1 specifies the Modules of the Mammography CAD SR IOD. A.X.1.3 Mammography CAD SR IOD Module Table Table A.X.1-1 specifies the Modules of the Mammography CAD SR IOD. Table A.X.1-1 MAMMOGRAPHY CAD SR IOD MODULES IE Module Reference Usage Patient Patient C M Specimen Identification C C - Required if the Observation Subject is a Specimen Study General Study C M

9 Page 9 Patient Study C U Series SR Document Series C.17.1 M Equipment General Equipment C M Document SR Document General C.17.2 M SR Document Content C.17.3 M SOP Common C.12.1 M A.X A.X Mammography CAD SR IOD Content Constraints Template Identification The Mammography CAD SR Document Root content item shall be ETID nnn1. When another document is quoted, the Document Root Node shall use TID 59, Quoted Document Root Context, and its subordinate templates, as described in Supplement 53, DICOM Part 16: Templates and Context Groups, Revision 18 or later. When a content item sub-tree from a quoted document is included by-value, its observation context shall be defined bytid 25, Quoted-Document Observation Context, and its subordinate templates, as described in Supplement 53, DICOM Part 16:Templates and Context Groups, Revision 18 or later. A.X Note: A.X Note: Value Type The Mammography CAD SR Document Root template and its subordinate templates make use of the following subset of the Value Type (0040,A040) as defined for the Comprehensive SR IOD: TEXT CODE NUM DATE TIME UIDREF PNAME SCOORD COMPOSITE IMAGE CONTAINER Relationship Constraints Table A.X.1-2 specifies the subset of the relationship constraints defined for the Comprehensive SR IOD.that are used by the Mammography CAD SR IOD. Table A.X.1-2 RELATIONSHIP CONTENT CONSTRAINTS FOR MAMMOGRAPHY CAD SR IOD Source Value Type Relationship Type (Enumerated Values) Target Value Type CONTAINER CONTAINS CODE, NUM, SCOORD, IMAGE 1, CONTAINER. TEXT, CODE, NUM, CONTAINER HAS OBS CONTEXT TEXT, CODE, NUM, DATE, TIME, UIDREF, PNAME IMAGE HAS ACQ CONTEXT TEXT, CODE, DATE, TIME. TEXT, CODE HAS PROPERTIES TEXT, CODE, NUM, DATE, IMAGE 1, SCOORD. CODE, NUM INFERRED FROM CODE, NUM, SCOORD.

10 Page 10 SCOORD SELECTED FROM IMAGE 1

11 Page 11 Part 3, Annex X Addendum Add the following to PS 3.3 ANNEX X (INFORMATIVE) X.1 Mammography CAD SR Content Tree Structure The Mammography CAD SR IOD is a constrained instance of the Comprehensive SR IOD. The templates are defined in Part 16 Annex X. a. All relationships defined in the Mammography CAD SR IOD templates are by-value, unless otherwise stated. b. Content items referenced from another SR object instance, such as a prior Mammography CAD SR, are duplicated by-value in the new SR object instance, with appropriate quoted document observation context. Document Root (CONTAINER) CONTAINS Image Library (CONTAINER) CONTAINS Summary of Detections (CODE) INFERRED FROM Summary of Analyses (CODE) INFERRED FROM Overall Impression/Recommendation INFERRED FROM HAS PROPERTIES Image Image Individual Impression/Recommendation Individual Impression/Recommendation HAS ACQUISITION CONTEXT HAS ACQUISITION CONTEXT INFERRED FROM INFERRED FROM Figure x.x.x.1: Top Levels of Mammography CAD SR Content Tree The Document Root, Image Library, Summaries of Detections and Analyses, and Overall Impression/Recommendation sub-trees together form the content tree of the Mammography CAD SR IOD.

12 Page 12 Summary of Detections (CODE) INFERRED FROM Summary of Analyses (CODE) INFERRED FROM Successful Detections (TEXT) Failed Detections (TEXT) Successful Analyses (TEXT) Failed Analyses (TEXT) HAS PROPERTIES HAS PROPERTIES HAS PROPERTIES HAS PROPERTIES Detection Performed Detection Performed Analysis Performed Analysis Performed HAS PROPERTIES HAS PROPERTIES HAS PROPERTIES HAS PROPERTIES Detection Performed Detection Performed Analysis Performed Analysis Performed HAS PROPERTIES HAS PROPERTIES HAS PROPERTIES HAS PROPERTIES Image Image Region Image Image Region SELECTED FROM SELECTED FROM Figure x.x.x.2: Summary of Detections and Analyses Levels of Mammography CAD SR Content Tree The Summary of Detections and Summary of Analyses sub-trees are used to identify the algorithms used and the work done by the CAD device. These sub-trees illuminate why CAD processing may not produce results (no findings), which occurs in three categories: a. All algorithms succeeded b. Some algorithms succeeded, some failed, but no findings resulted c. All algorithms failed Note 1: Note 2: Note 3: If the tree contains no Individual Impression/Recommendation nodes and all attempted detections and analyses succeeded then the CAD device made no findings. Detections and Analyses that are not attempted are not listed in the Summary of Detections and Summary of Analyses trees. If the code value of the Summary of Detections or Summary of Analyses codes in TID nnn1 is Not Attempted then no detail of which algorithms were not attempted is provided.

13 Page 13 Individual Impression/Recommendation INFERRED FROM HAS PROPERTIES ANALYSES Composite Feature (Code) INFERRED FROM Single Image Finding (Code = CALC CLUSTER) INFERRED FROM HAS PROPERTIES Single Image Finding (Code = DENSITY) HAS PROPERTIES Single Image Finding (Code) Composite Feature (Code) Single Image Finding (Code = IND CALC) Single Image Finding (Code = IND CALC) INFERRED FROM INFERRED FROM HAS PROPERTIES HAS PROPERTIES Single Image Finding (Code) HAS PROPERTIES Single Image Finding (Code) HAS PROPERTIES DETECTIONS Figure x.x.x.3: Individual Impression/Recommendation Levels of Mammography CAD SR Content Tree The shaded area in Figure x.x.x.3 demarcates information resulting from Detection, whereas the unshaded area is information resulting from Analysis. This distinction is used in determining whether to place algorithm identification information in the Summary of Detections or Summary of Analyses subtrees. The clustering of calcifications within a single image is considered to be a Detection process which results in a Single Image Finding. The spatial correlation of a calcification cluster in two views, resulting in a Composite Feature, is considered Analysis. The clustering of calcifications in a single image is the only circumstance in which a Single Image Finding can result from the combination of other Single Image Findings, which must be Individual Calcifications. Once a Single Image Finding or Composite Feature has been instantiated, it may be referenced by any number of Composite Features higher in the tree. X.2 Mammography CAD SR Observation Context Encoding Any content item in the Content tree that has been duplicated (i.e., quoted) from another SR object instance has a HAS OBS CONTEXT relationship to one or more content items that describe the context of the SR object instance from which it originated, as a quoted document. This mechanism may be used to combine reports (e.g., CAD 1, CAD 2, Human). Content items do not overwrite the Initial Observation Context defined outside the SR Document Content tree by other modules in the SR IOD (e.g., Patient, General Equipment, SR Document General modules). Context is not inherited in by reference relationships. The Impression/Recommendation section of the SR Document Content tree of a Mammography CAD SR IOD may contain a mixture of current (direct) and prior (quoted) single image findings and composite features. The content items from current and prior contexts are target content items that have a by-value

14 Page 14 INFERRED FROM relationship to a Composite Feature content item. Content items quoted from a context other than the Initial Observation Context have a HAS OBS CONTEXT relationship to target content items that describe the context of the quoted document. In the following example, Composite Feature and Single Image Finding 1 are current, and Single Image Finding 2 is quoted from a prior document. Composite Feature (Code) INFERRED FROM Single Image Finding 1 (Code) Single Image Finding 2 (Code) HAS OBS CONTEXT Quoted Document Context Info. HAS PROPERTIES HAS PROPERTIES X.3 Mammography CAD SR Examples The following is a simple and non-comprehensive illustration of an encoding of the Mammography CAD SR IOD for Mammography computer aided detection results. Example 1: Calcification and Mass Detection with No Findings A CAD device processes a typical screening mammography case, i.e., there are four films and no cancer. CAD runs both density and calcification detection successfully and finds nothing. The mammograms resemble: RCC LCC RMLO LMLO The content tree structure would resemble: Node of Concept Name of Value TID 1 Mammography CAD SR Image Library 1

15 Page 15 Node of Concept Name of Value TID Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Cranio-caudal Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Cranio-caudal Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Medio-lateral oblique Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Medio-lateral oblique Summary of Detections Succeeded Successful Detections Detection Performed Density Algorithm ID Density Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Detection Performed Individual Calcification Algorithm ID Calc Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Summary of Analyses Not Attempted Overall Impression/Recommendation All algorithms succeeded; without findings 2 Example 2: Calcification and Mass Detection with Findings A CAD device processes a screening mammography case with four films and a mass in the left breast. CAD runs both density and calcification detection successfully. It finds two densities in the LCC, one density in the LMLO, a cluster of three calcifications in the RCC and a cluster of 20 calcifications in the

16 Page 16 RMLO. It performs two clustering algorithms. One identifies individual calcifications and then clusters them, and the second simply detects calcification clusters. It performs mass correlation and combines one of the LCC densities and the LMLO density into a mass; the other LCC density is flagged Not for Presentation, therefore not intended for display to the end-user. The mammograms resemble: RCC LCC RMLO LMLO The content tree structure would resemble (preliminary diagram): Mammography CAD SR CONTAINER CONTAINS CONTAINS CONTAINS CONTAINS IMAGE LIBRARY CONTAINER SUMMARY OF DETECTIONS CODE: SUCCEEDED SUMMARY OF ANALYSES CODE: SUCCEEDED OVERALL IMPRESSION/ RECOMMENDA TION CONTAINS CONTAINS HAS PROP HAS PROP IMAGE REFERENCE IMAGE REFERENCE IMAGE REFERENCE IMAGE REFERENCE DETECTION PERFORMED DETECTION PERFORMED DETECTION PERFORMED CODE: DETECTION CALCIFICATION PERFORMED CODE: CALCIFICATION CODE: CLUSTER CALCIFICATION CODE: CLUSTER CALCIFICATION CLUSTER CLUSTER ANALYSIS PERFORMED CODE: MASS CORRELATION ANALYSIS PERFORMED CODE: MASS CORRELATION HAS PROP HAS PROP HAS PROP HAS PROP IMAGE LATERALITY IMAGE LATERALITY IMAGE IMAGE LATERALITY IMAGE CODE IMAGE LATERALITY VIEW CODE IMAGE SEQUENCE VIEW CODE IMAGE SEQUENCE VIEW CODE SEQUENCE VIEW SEQUENCE INFER INFER INFER INFER HAS PROP HAS PROP HAS PROP HAS PROP ALGORITHM ID "CALC ALGORITHM CLUSTERID "CALC ALGORITHM DETECTOR" CLUSTERID "CALC ALGORITHM DETECTOR" CLUSTERID ALGORITHM "CALC DETECTOR" CLUSTER VERSION ALGORITHM DETECTOR" "V2.4" VERSION ALGORITHM "V2.4" VERSION ALGORITHM "V2.4" VERSION "V2.4" INFER HAS PROP ALGORITHM ID "MASS MAKER" ALGORITHM VERSION "V1.9" INFER HAS PROP ALGORITHM ID "MASS MAKER" ALGORITHM VERSION "V1.9" Node of Concept Name of Value TID 1 Mammography CAD SR Image Library 1

17 Page 17 Node of Concept Name of Value TID Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Cranio-caudal Study Date Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Cranio-caudal Study Date Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Medio-lateral oblique Study Date Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Medio-lateral oblique Study Date Summary of Detections Succeeded Successful Detections Detection Performed Density Algorithm ID Density Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Detection Performed Individual Calcification Algorithm ID Calc Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Detection Performed Calcification Cluster Algorithm ID Calc Clustering Algorithm Version V Reference to node

18 Page 18 Node of Concept Name of Value TID Detection Performed Calcification Cluster Algorithm ID Calc Cluster Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Summary of Analyses Succeeded Successful Analyses Analysis Performed Mass Correlation Algorithm ID Mass Maker Algorithm Version V Reference to node Reference to node Overall Impression/Recommendation All algorithms succeeded; with findings Individual Impression/Recommendation INDIVIDUAL Rendering Intent Presentation Required Composite Feature Mass Composite type Target content items are related spatially Scope of Feature Feature was detected on multiple images Rendering Intent Presentation Required Single Image Finding Density Rendering Intent Presentation Required Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Density Rendering Intent Presentation Required Area Measurement Area of Defined Region Measurement Name Area of density 23.2

19 Page 19 Node of Concept Name of Value TID Area 2 cm Area Outline SCOORD Reference to node Center POINT Reference to node Outline SCOORD Reference to node Individual Impression/Recommendation INDIVIDUAL Rendering Intent Not for Presentation Single Image Finding Density Rendering Intent Not for Presentation Center POINT Reference to node Outline SCOORD Reference to node Individual Impression/Recommendation INDIVIDUAL Rendering Intent Presentation Required Single Image Finding Calcification Cluster Rendering Intent Presentation Required Number of Calcifications Center POINT Reference to node Outline SCOORD Reference to node Individual Impression/Recommendation INDIVIDUAL Rendering Intent Presentation Required Single Image Finding Calcification Cluster Rendering Intent Presentation Required Number of Calcifications Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional 9

20 Page 20 Node of Concept Name of Value TID Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Example 3: Calcification and Mass Detection, Temporal Differencing with Findings The patient in Example 2 returns for another mammogram. A more comprehensive CAD (CADx) device processes the current mammogram. The prior CAD report (from Example 2) is referenced and sections of the content tree from the prior CAD report are incorporated. In the current mammogram the number of calcifications in the RCC has increased, and the size of the mass in the left breast has increased from 2 to 4 cm 2.

21 Page 21 Prior RCC LCC RMLO LMLO Current RCC LCC RMLO LMLO Bolded entries (xxx) in the following table denote references to or by-value inclusion of quoted content tree items from a prior Mammography CAD SR instance (see example 2). Node of Concept Name of Value TID 1 Mammography CAD SR 1 1.x Observation Context of Quoted Document Root Image Library Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Cranio-caudal Study Date Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Cranio-caudal Study Date Image Used As Evidence IMAGE 3 22

22 Page 22 Node of Concept Name of Value TID Image Laterality Right Image View Code Sequence Medio-lateral oblique Study Date Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Medio-lateral oblique Study Date Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Cranio-caudal Study Date Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Cranio-caudal Study Date Image Used As Evidence IMAGE Image Laterality Right Image View Code Sequence Medio-lateral oblique Study Date Image Used As Evidence IMAGE Image Laterality Left Image View Code Sequence Medio-lateral oblique Study Date Summary of Detections Succeeded Successful Detections Detection Performed Density Algorithm ID Density Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Detection Performed Individual Calcification Algorithm ID Calc Detector Algorithm Version V Reference to node Reference to node

23 Page 23 Node of Concept Name of Value TID Reference to node Reference to node Detection Performed Calcification Cluster Algorithm ID Calc Clustering Algorithm Version V Reference to node Detection Performed Calcification Cluster Algorithm ID Calc Cluster Detector Algorithm Version V Reference to node Reference to node Reference to node Reference to node Summary of Analyses Succeeded Successful Analyses Analysis Performed Mass Correlation Algorithm ID Mass Maker Algorithm Version V Reference to node Reference to node Overall Impression/Recommendation All algorithms succeeded; with findings Assessment Category 4 Suspicious abnormality, biopsy should be considered Recommend Follow-up Interval 0 days Individual Impression/Recommendation INDIVIDUAL Rendering Intent Presentation Required Differential Diagnosis/Impression Increase in size Impression description Worrisome increase in size Certainty of impression 84% Recommended Follow-up Needle localization and biopsy (L) 3 3

24 Page 24 Node of Concept Name of Value TID Composite Feature Mass Composite type Target content items are related temporally Scope of Feature Feature was detected on multiple images Rendering Intent Presentation Required Certainty of Feature 91% Probability of Cancer 84% Pathology Lobular carcinoma in situ Quantitative Difference Size Difference value A-B 2 cm Reference to node Reference to node Lesion Density High density Shape Lobular Margins Microlobulated Composite Feature Mass Composite type Target content items are related spatially Scope of Feature Feature was detected on multiple images Rendering Intent Presentation Required Single Image Finding Density Rendering Intent Presentation Required Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Density Rendering Intent Presentation Required Area Measurement Area of Defined Region Measurement Name Area of density Area 4 cm Area Outline SCOORD Reference to node Center POINT Reference to node

25 Page 25 Node of Concept Name of Value TID Outline SCOORD Reference to node Composite Feature Mass Composite type Target content items are related spatially Scope of Feature Feature was detected on multiple images Rendering Intent Presentation Required Observation Context of Quoted Document Single Image Finding Density Rendering Intent Presentation Required Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Density Rendering Intent Presentation Required Area Measurement Area of Defined Region Measurement Name Area of density Area 2 cm Area Outline SCOORD Reference to node Center POINT Reference to node Outline SCOORD Reference to node Individual Impression/Recommendation INDIVIDUAL Rendering Intent Not for Presentation Single Image Finding Density Rendering Intent Not for Presentation Center POINT Reference to node Outline SCOORD Reference to node Individual Impression/Recommendation INDIVIDUAL 4

26 Page 26 Node of Concept Name of Value TID Rendering Intent Presentation Required Single Image Finding Calcification Cluster Rendering Intent Presentation Required Number of Calcifications Center POINT Reference to node Outline SCOORD Reference to node Individual Impression/Recommendation INDIVIDUAL Rendering Intent Presentation Required Differential Diagnosis/Impression Increase in number of calcifications Impression description Calcification cluster has increased in size Certainty of impression 100% Recommended Follow-up Magnification views (M) Composite Feature Calcification Cluster Composite type Target content items are related temporally Scope of Feature Feature was detected on multiple images Rendering Intent Presentation Required Certainty of Feature 99% Probability of Cancer 54% Pathology Ductal carcinoma in situ Quantitative Difference Number of Calcifications Difference value A-B Reference to node Reference to node Calcification type Fine, linear, branching (casting) Calcification distribution Grouped or clustered Single Image Finding Calcification Cluster Rendering Intent Presentation Required Number of Calcifications Center POINT Reference to node

27 Page 27 Node of Concept Name of Value TID Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional 9

28 Page 28 Node of Concept Name of Value TID Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Calcification Cluster Rendering Intent Presentation Required Number of Calcifications Observation Context of Quoted Document Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Single Image Finding Individual Calcification Rendering Intent Presentation Optional Center POINT Reference to node Outline SCOORD Reference to node Refers to a Supplement 53 Revision 18 template ID; subject to change prior to Supplement 53 approval.

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30 Page 30 Part 4 Addendum Update Annex B and I SOP Class tables Add Mammography CAD SR Storage SOP Class to Table B.5-1 B.5 STANDARD SOP CLASSES SOP Class Name SOP Class UID IOD (See PS 3.3) Mammography CAD SR Mammography CAD SR IOD B Structured Reporting Storage SOP Classes For SOP classes Basic Text SR, Enhanced SR, Comprehensive SR and Mammography CAD SR ssee Annex O. Add Mammography CAD SR Storage Media Storage SOP Classes to Table I.4-1 I.4 MEDIA STANDARD STORAGE SOP CLASSES SOP Class Name SOP Class UID IOD (See PS 3.3) Mammography CAD SR Mammography CAD SR IOD Update Annex O O.2.x Mammography CAD SR SOP Class The Mammography CAD SR object contains data not only for presentation to the clinician, but also data solely for use in subsequent CAD analyses. The SCU provides rendering guidelines via Rendering Intent content items associated with Individual Impression/Recommendation, Composite Feature and Single Image Finding content items. The full meaning of the SR is provided if the tree is rendered down to the first instance of Not for Presentation or Presentation Optional for each branch of the tree. Use of the SCU s Conformance Statement is recommended if further enhancement of the meaning of the SR can be accomplished by rendering some or all of the data marked Presentation Optional. Data marked Not for Presentation should not be rendered by the SCP _ it is embedded in the SR content tree as input to subsequent Mammography CAD analysis work steps. SCP devices creating human readable text output shall (when available) render content in the most human readable form. For instance, if quadrant and clock-face information is not available as an alternate for SCOORD data, then the SCOORD feature location shall be rendered either in (X,Y) pixel coordinates or (X,Y) in distance units. O.4.1.x Mammography CAD SR SOP Class The following shall be documented in the Conformance Statement of any implementation claiming conformance to the Mammography CAD SR SOP Class as an SCU: Which algorithms the device is capable of performing: From detections listed in CID

31 From analyses listed in CID xxxx9 Which optional content items are supported Supplement 50: Mammography CAD SR SOP Class Page 31 Recommendations to SCPs regarding the rendering of Presentation Optional content items Recommendations to SCPs regarding how to render to the clinician the Presentation Required SCOORD content items O.4.2.x Mammography CAD SR SOP Class The following shall be documented in the Conformance Statement of any implementation claiming conformance to the Mammography CAD SR SOP Class as an SCP: In what manner the SCP renders the SCOORD content items Whether the SCP will render Presentation Optional content items

32 Page 32 Part 6 Addendum ANNEX A (NORMATIVE): REGISTRY OF DICOM UNIQUE IDENTIFIERS (UID) Add the following UIDs to Part 6 Annex A: UID Value UID NAME UID TYPE Part Mammography CAD SR SOP Class 3.4

33 Page 33 Part 16 Addendum ANNEX X: MAMMOGRAPHY CAD SR IOD TEMPLATES Add the following Templates to Part 16 Annex X: The templates that comprise the Mammography CAD SR IOD are interconnected as follows: TID nnn1 Mammography CAD SR Document Root TID nnn19.1 Detections Performed TID nnn20 Detection Performed TID nnn21.5 Algorithm Identification TID nnn19.2 Analyses Performed TID nnn21 Analysis Performed TID nnn21.5 Algorithm Identification TID nnn2 Overall impression /recommendation TID nnn22 Image library TID nnn3 Impression body TID nnn4 Individual impression /recommendation TID nnn3 Impression body TID nnn5 Composite feature TID nnn5 Composite feature TID nnn9 Single image finding TID nnn9 Single image finding TID nnn11 Breast Composition TID nnn12 Breast Geometry TID nnn13.1 Individual Calcification TID nnn13.2 Calcification Cluster TID nnn14 Density TID nnn15 Nipple TID nnn16 Non-lesion TID nnn17 Selected Region TID nnn18 Image quality TID nnn21.5 Algorithm Identification TID nnn10 Generic TID nnn25 Geometry TID nnn6 Composite feature body TID nnn25 Geometry TID nnn23.1, 23.2, 23.3 Measurement TID nnn21.5 Algorithm Identification

34 Page 34 TID nnn1 Mammography CAD SR IOD Document Root Template This template forms the top of a content tree that allows a CAD device to describe the results of detection and analysis of Mammographic evidence. This template, together with its subordinate templates, describes both the results for presentation to radiologists and partial product results for consumption by CAD devices in subsequent CAD reports. This template defines a Container which contains an Image Library, summaries of detection and analysis algorithms performed, and the CAD results. The Image Library contains the Image SOP Class and Instance UIDs, and selected attributes for each image referenced in either the algorithm summaries or CAD results. The Summary of Detections and Summary of Analyses Containers gather lists of algorithms attempted, grouped by success/failure status. Algorithms not attempted are not mentioned in these Containers. This information forms the basis for understanding why a CAD report may produce no (or fewer than anticipated) results. CAD results are constructed bottom-up, starting from Single Image Findings (see Template nnn9), associated as Composite Features (see Template nnn5), and from which Individual and Overall Impressions are formed. The tree headed by this template is illustrated in Figure x.x.x.1 of Part 3, Annex X (Mammography CAD SR Content Tree Structure). TID nnn1 MAMMOGRAPHY CAD SR IOD DOCUMENT ROOT NL Rel with Parent VT Concept Name VM Req Type Condition Value Set Constraint 1 CONTAINER (cv, csd, Mammography CAD 1 M SR ) 2 > HAS OBS CONTEXT INCLUDE ETID (TID nnn59) Quoted Document Root Context 3 > CONTAINS CONTAINER (cv, csd, Image Library ) 1 M 4 >> CONTAINS INCLUDE ETID (TID nnn22) Image Library Entry 5 > CONTAINS CODE (cv, csd, Summary of Detections ) 6 >> INFERRED FROM INCLUDE ETID (TID nnn19.1) Detections Performed 7 > CONTAINS CODE (cv, csd, Summary of Analyses ) 8 >> INFERRED FROM INCLUDE ETID (TID nnn19.2) Analyses Performed 9 > CONTAINS INCLUDE ETID (TID nnn2) Overall Impression / Recommendation 1-n MC Required if another document is quoted within this document. 1-n M 1 M ECID (CID xxxx8) Status of Results 1 MC Shall be present only if the Summary of Detections is not Not Attempted 1 M ECID (CID xxxx8) Status of Results 1 MC Shall be present only if the Summary of Analyses is not Not Attempted 1 M