Customer Technical Reference. DICOM Conformance Statement: Proton Therapy Imaging

Transcription

1 Customer Technical Reference DICOM Conformance Statement: Proton Therapy Imaging PB-CTR Nov-2016

2 Abstract Manufacturer This document contains important information on the handling and use of the product as well as on the safety measures to be observed. Varian Medical Systems Particle Therapy GmbH Mottmannstraße Troisdorf GERMANY Tel.: +49 (2241) Fax: +49 (2241) Notice FDA 21 CFR 820 Quality System Regulation (cgmps) For questions and feedback on this document contact: PT-Technical-Publication.DEBG@varian.com Information in this document is subject to change without notice and does not represent a commitment on the part of Varian. Varian is not liable for errors contained in this document or for incidental or consequental damages in connection with furnishing or use of this material. This document contains proprietary information protected by copyright. No part of this document may be reproduced, translated or transmitted without the express written permission of Varian Medical Systems. Varian Medical Systems products are designed and manufactured in accordance with the requirements specified within this federal regulation. ProBeam proton therapy system meets the requirements of Council Directive MDD 93/42/EEC. ISO HIPAA Varian Medical Systems products are designed and manufactured in accordance with the requirements specified within the ISO quality standard. Varian's products and services are specifically designed to include features that help our customer comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). US Federal law restricts this device to sale by or on the order of a physician. Trademark Copyright ProBeam proton therapy system is a registered trademark of Varian Medical Systems. Microsoft and Windows are registered trademarks of Microsoft Corporation. All other trademarks or registered trademarks are the property of their respective owners Varian Medical Systems Particle Therapy GmbH All rights reserved. Document ID PB-CTR Version ProBeam 3.1; ProBeam 3.0

3 Table of Contents 1 Introduction Overview Audience Remarks Terms and Definitions Abbreviations References Networking Implementation Model Application Data Flow Functional Definition of AEs Sequencing of Real-World Activities AE Specifications SOP Classes Association Policies Association Initiation Policy Association Acceptance Policy Network Interfaces Configuration AE Title/Presentation Address Mapping Parameters Media Interchange Support of Character Sets Security Security Profiles Association Level Security Application Level Security Appendix A - Specialization A.1 IOD Contents A.1.1 Created SOP Instances A.1.2 Usage of Attributes from Received IODs A.2 Data Dictionary of Private Attributes A.3 Coded Terminology and Templates A.3.1 Context Groups A.3.2 Template Specifications A.3.3 Private Code Definitions Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

4 Table of Contents A.4 Grayscale Image Consistency A.5 Standard Extended/Specialized/Private SOP Classes A.6 Private Transfer Syntaxes Appendix B - IOD Details B.1 IODs B.1.1 Computed Tomography Image A B.1.2 Spatial Registration A B.1.3 RT Structure Set A B.1.4 RT Image A B.2 Modules and Attributes B.2.1 Patient C B.2.2 General Study - C B.2.3 General Series C B.2.4 Frame of Reference C B.2.5 General Equipment C B.2.6 General Image C B.2.7 Image Plane C B.2.8 Image Pixel C B.2.9 CT Image C B.2.10 RT Series C B.2.11 RT Image C B.2.12 Structure Set C B.2.13 Approval C B.2.14 Modality LUT C B.2.15 VOI LUT C B.2.16 SOP Common C B.2.17 Common Instance Reference C B.2.18 Spatial Registration Series C B.2.19 Spatial Registration C Appendix C - Extended Interface /80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

5 1 Introduction 1.1 Overview The Proton Therapy Imaging (PTI) application, part of Varian's ProBeam proton therapy system, is used to set up a patient for treatment purposes. To support this function, DICOM services are used for receiving and sending data from/to diagnostic imaging modalities. This document describes PTI compliance to DICOM conformance requirements. The table below lists the network services supported by the PTI application. Service SOP Class User of Service (SCU) Provider of Service (SCP) Transfer CT Image Storage Yes Yes Transfer Spatial Registration Storage Yes No Transfer RT Structure Set Storage Yes Yes Transfer RT Image Storage Yes Yes Transfer RT Ion Plan Storage No Yes Query/Retrieve Query/Retrieve Study Root Query/Retrieve Information Model FIND Study Root Query/Retrieve Information Model MOVE No Yes No No The table below lists the media file SOP classes supported for file-based export and import. These SOP classes are supported only when the PTI is operating in file mode. SOP Classes DICOM Media File Export DICOM Media File Import CT Image Storage Yes Yes Spatial Registration Storage Yes No RT Structure Set Storage Yes Yes RT Image Storage Yes Yes RT Ion Plan Storage No Yes 1.2 Audience This document is written for the people who need to understand how Varian s ProBeam system can be integrated into their healthcare facility. This includes both those responsible for overall imaging network policy and architecture, as well as integrators who need to have a detailed understanding of the DICOM features of the product. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

6 1 Introduction This document contains some basic DICOM definitions so the reader can understand how this product implements the DICOM features. It is assumed that integrators are well-versed in DICOM, and that they fully understand DICOM terminology, how the tables in this document relate to the product's functionality, and how that functionality integrates with other devices that support compatible DICOM features. 1.3 Remarks This Conformance Statement should be read and understood in conjunction with the DICOM Standard Version DICOM by itself does not guarantee interoperability; the Conformance Statement, however, facilitates a first-level comparison for interoperability between different applications supporting compatible DICOM functionality. This Conformance Statement is not intended to replace validation with other DI- COM equipment to ensure proper exchange of information intended. Because the DICOM standard is subject to ongoing changes, enhancements and improvements, Varian Medical Systems reserves the right to advance their products by making use of upcoming DICOM features. This document contains definitions which are specific to the Proton Therapy Imaging application (PTI). For definitions that are specific to the Proton Treatment Console (PTC), see Proton Treatment Console DICOM Conformance Statement. Otherwise, all definitions of the Varian System Server DICOM conformance statement apply as applicable; see Varian System Server DICOM Conformance Statement. See also 2 References [} 10] 1.4 Terms and Definitions The table below contains informal definitions of terms used in ProBeam DICOM Conformance Statements. The DICOM Standard is the authoritative source for formal definitions of these terms. Abstract Syntax Application Entity (AE) The information agreed to be exchanged between applications, generally equivalent to a Service/Object Pair (SOP) Class. Examples: Verification SOP Class, Modality Worklist Information Model Find SOP Class, Computed Radiography Image Storage SOP Class. An end point of a DICOM information exchange, including the DICOM network or media interface software; i.e., the software that sends or receives DI- COM information objects or messages. A single device may have multiple Application Entities. 6/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

7 1.4 Terms and Definitions Application Entity Title (AET) Application Context Association Attribute Information Object Definition (IOD) Media Application Profile Module Negotiation Presentation Context ProBeam Protocol Data Unit (PDU) The externally known name of an Application Entity, used to identify a DICOM application to other DI- COM applications on the network. The specification of the type of communication used between Application Entities. Example: DICOM network protocol. A network communication channel set up between Application Entities. A unit of information in an object definition; a data element identified by a tag. The information may be a complex data structure (Sequence), itself composed of lower level data elements. Examples: Patient ID (0010,0020), Accession Number (0008,0050), Photometric Interpretation (0028,0004), Procedure Code Sequence (0008,1032). The specified set of Attributes that comprise a type of data object; does not represent a specific instance of the data object, but rather a class of similar data objects that have the same properties. The Attributes may be specified as Mandatory (Type 1), Required but possibly unknown (Type 2), or Optional (Type 3), and there may be conditions associated with the use of an Attribute (Types 1C and 2C). Examples: MR Image IOD, CT Image IOD, Print Job IOD. The specification of DICOM information objects and encoding exchanged on removable media (e.g., CDs). A set of Attributes within an Information Object Definition that are logically related to each other. Example: Patient Module includes Patient Name, Patient ID, Patient Birth Date, and Patient Sex. First phase of Association establishment that allows Application Entities to agree on the types of data to be exchanged and how that data will be encoded. The set of DICOM network services used over an Association, as negotiated between Application Entities; includes Abstract Syntaxes and Transfer Syntaxes. Varian s ProBeam System is a proton therapy system used to treat various forms of cancer and related conditions. A packet (piece) of a DICOM message sent across the network. Devices must specify the maximum size packet they can receive for DICOM messages. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

8 1 Introduction Security Profile Service Class Provider (SCP) Service Class User (SCU) Service/Object Pair Class (SOP Class) Service/Object Pair Instance (SOP Instance) Tag Transfer Syntax Transmission Control Protocol/ Internet Protocol (TCP/IP) Treatment Management System Unique Identifier (UID) A set of mechanisms, such as encryption, user authentication, or digital signatures, used by an Application Entity to ensure confidentiality, integrity, and/or availability of exchanged DICOM data. Role of an Application Entity that provides a DICOM network service; typically, a server that performs operations requested by another Application Entity (Service Class User). Examples: Picture Archiving and Communication System (image storage SCP, and image query/retrieve SCP), Radiology Information System (modality worklist SCP). Role of an Application Entity that uses a DICOM network service; typically, a client. Examples: imaging modality (image storage SCU, and modality worklist SCU), imaging workstation (image query/retrieve SCU). The specification of the network or media transfer (service) of a particular type of data (object); the fundamental unit of DICOM interoperability specification. Examples: Ultrasound Image Storage Service, Basic Grayscale Print Management. An information object; a specific occurrence of information exchanged in a SOP Class. Examples: a specific x-ray image. A 32-bit identifier for a data element, represented as a pair of four digit hexadecimal numbers, the "group" and the "element". If the "group" number is odd, the tag is for a private (manufacturer-specific) data element. Examples: (0010,0020) [Patient ID], (07FE,0010) [Pixel Data], (0019,0210) [private data element]. The encoding used for exchange of DICOM information objects and messages. Examples: JPEG compressed (images), little endian explicit value representation. A widely used computer networking protocol. DICOM entity from which the ProBeam Imaging application retrieves structure set data. A globally unique "dotted decimal" string that identifies a specific object or a class of objects; an ISO-8824 Object Identifier. Examples: Study Instance UID, SOP Class UID, SOP Instance UID. 8/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

9 1.5 Abbreviations Value Representation (VR) The format type of an individual DICOM data element, such as text, an integer, a person's name, or a code. DICOM information objects can be transmitted with either explicit identification of the type of each data element (Explicit VR), or without explicit identification (Implicit VR); with Implicit VR, the receiving application must use a DICOM data dictionary to look up the format of each data element. 1.5 Abbreviations AE AET CT DICOM DIMSE HIS HL7 IHE IOD ISO JPEG MPEG NEMA PACS PDU PET PTC SCP SCU SOP SPS SR TCP/IP U UID UL VR Application Entity Application Entity Title Computed Tomography Digital Imaging and Communications in Medicine DICOM Message Service Element Hospital Information System Health Level 7 standard Integrating the Healthcare Enterprise Information Object Definition International Organization for Standards Joint Photographic Experts Group Moving Picture Experts Group National Electrical Manufacturers Association Picture Archiving and Communication System Protocol Data Unit Positron Emission Tomography Proton Treatment Console application for ProBeam Service Class Provider Service Class User Service-Object Pair Scheduled Procedure Step Structured Reporting Transmission Control Protocol/Internet Protocol Unique (Key Attribute) Unique Identifier Upper Layer Value Representation 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

10 1 Introduction 1.6 References [1] Digital Imaging and Communications in Medicine (DICOM), Parts 1-18 (2011), National Electrical Manufacturers Association (NEMA) Rosslyn, VA, USA available free at [2] Proton Treatment Console DICOM Conformance Statement P/N Varian Medical Systems Inc Palo Alto, CA, USA [3] Varian System Server DICOM Conformance Statement B VA11002D3CS (System Server version 11) B VA1302D3CS (System Server version 13) Varian Medical Systems International AG Baden, Switzerland [4] IHE Radiation Oncology Technical Framework Supplement Multimodality Image Registration for Radiation Oncology 2012 (MMRO-II) ftp://ftp.ihe.net/radiationoncology/supplements/mmro-ii/ihe-ro_mmro-ii_supplement_v1-0_ docx 10/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

11 2 Networking 2.1 Implementation Model Application Data Flow Fig. 1: Implementation Model Conceptually, the network services may be modeled as the following separate AEs, though in fact all the AEs share a single (configurable) AE Title: STORAGE-SCP, which receives incoming RT images, CT images, RT Ion Plans and Structure Sets. STORAGE-SCU, which sends outbound RT images, CT images, Structure Sets and Spatial Registrations. MOVE-SCU, which retrieves selected studies, series or instances. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

12 2 Networking ECHO-SCU, which sends outgoing echo request to Remote Application Entity Functional Definition of AEs Conceptually, the network services may be modeled as the following separate AEs, though in fact all the AEs share a single (configurable) AE Title: ProBeam Imaging Client Storage SCU Application Entity The Storage SCU Application Entity is invoked when A 2D/3D, marker or 3D/3D matching has been performed and Spatial Registrations or Markers must be sent to the Remote AE. A 3D/3D matching has been performed and the acquired CT set must be sent to the Remote AE Marker Detection has been performed and the markers must be sent to the Remote AE as Structure set linked to the current reference CT image. Each marker is defined as own point set with a single point in it. Marker Match has been performed, the markers are stored as curves in the image object and the image object must be sent to the Remote AE. When the user saves an acquired image through the UI, the image is then sent to the Remote AE. The treatment fraction is closed and all unsaved acquired images and other IODs are sent to the Remote AE ProBeam Imaging Client Query/Retrieve SCU Application Entity The Query/Retrieve Application Entity is invoked when The patient is loaded in the ProBeam Treatment application, and reference images need to be loaded in ProBeam Imaging Structure Set and CT images must be loaded in order to perform marker detection/ matching, 2D/3D matching, 3D/3D matching or to generate DRRs ProBeam Imaging Client Storage SCP Application Entity The Storage SCP Application Entity is invoked in order to receive objects requested from a remote Query/Retrieve SCP, such as: Reference Images Structure Sets RT Ion Plan Reference CT image set Sequencing of Real-World Activities When a patient is loaded into the application, the application loads each reference image by requesting them from the remote AE. 12/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

13 2.1 Implementation Model Referenced structure set and related CT images are loaded if the plan defines the RT structure set on which the RT Ion plan is based on in the plan s Referenced Structure Set Sequence (300C, 0060). The application invokes a move command for each CT Image related to the structure set represented by the CT Image Query/Retrieve SCU. For this purpose, the application provides the CT Image Storage SCP. When Marker Detection is performed, Storage SCU entity is invoked and the Marker Data (as Structure Set) are stored to the remote AE. When either a 2D/3D, 3D/3D or marker matching is performed, the Storage SCU entity is invoked and stores a Spatial Registration to the remote AE When loading from or saving to the Remote Application Entity, the ECHO-SCU entity is typically invoked to ensure that the remote AE is alive and responsive. The loading of a reference CT set is described by the following sequence diagram, which illustrates, that the plan and the structure set is retrieved as well to follow the appropriate references: Fig. 2: Sequence Diagram for CT Set loading 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

14 2 Networking 2.2 AE Specifications SOP Classes The PTI Application Entity provides standard conformance to the DICOM SOP classes listed in the table below. Presentation Context Table Abstract Syntax Transfer Syntax Role Ext. Neg. Name UID Name UID RT Structure Set Storage Spatial Registration Storage CT Image Storage RT Image Storage DICOM Implicit VR Little Endian DICOM Implicit VR Little Endian DICOM Explicit VR Little Endian DICOM Implicit VR Little Endian DICOM Implicit VR Little Endian DICOM Implicit VR Little Endian DICOM Explicit VR Little Endian DICOM Implicit VR Little Endian DICOM Implicit VR Little Endian DICOM Explicit VR Little Endian SCU None SCP None SCP None SCU None SCU None SCP None SCP None SCU None SCP None SCP None 14/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

15 2.2 AE Specifications Presentation Context Table Abstract Syntax Transfer Syntax Role Ext. Neg. Name UID Name UID RT Ion Plan Storage Study Root Query/Retrieve information model- MOVE DICOM Implicit VR Little Endian DICOM Explicit VR Little Endian DICOM Implicit VR Little Endian SCP None SCP None SCU None Association Policies General The DICOM standard application context name for DICOM 3.0 is always proposed. The DICOM Application Context Name for the PTI client Application Entity is Number of Associations The PTI client Application Entity can initiate (by default) up to three associations at a time. This value is configurable Asynchronous Nature The PTI client Application Entity does not support asynchronous communication Implementation-Identifying Information The following Implementation Class UID is used. This UID is not configurable. UID Value UID Name PTI Imaging for ProBeam (P2VA) Association Initiation Policy The PTI client Application Entity does initiate Associations. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

16 2 Networking Activity Store Description and Sequencing of Activities When the user performs a 2D/3D, marker, or 3D/3D matching, the match transformation is stored as a Spatial Registration IOD. When the user performs marker detection on the reference CT image, the positions of the detected markers are stored in the Structure Set and linked to the current reference CT image. When the user performs a marker match, the positions of the matched markers are stored in the acquired RT Image object as curves with the following values: Curve Dimensions (5002,0005): 2 Number of Points (5002,0010): 1 Type of Data (5000,0020): POLY Axis Units (5000,0030): PIXL\PIXL Axis Labels (5000,0040): Marker\Marker Data Value Representation (5000,0103): 3 When the user acquires a verification CT set, each CT Image is stored. The following isocenters are stored as Points in the Structure Set, which is linked to the acquired verification CT set. The values of the RT ROI Interpreted Type (3006,00A4) are as follows: Initial Laser Isocenter (position before acquisition, e.g. initial setup position): INITLASERISO Acquisition Isocenter (position during acquisition): ACQ_ISOCENTER Initial Match Isocenter (position when first match was started): INIT- MATCHISO The Storage SCU is invoked and attempts to initiate a new Association. If multiple objects are to be transferred, then multiple C-STORE requests are issued over this Association. The table below lists the object categories used by the PTI client Storage SCU Application Entity. Object Category SOP Class Name SOP Class UID Structure Set RT Structure Set Storage Spatial Registration Spatial Registration Storage RT Image RT Image Storage CT Image CT Image Storage Proposed Presentation Contexts The PTI client Storage SCU Application Entity is capable of proposing the Presentation Contexts shown in the table below. 16/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

17 2.2 AE Specifications Presentation Context Table Abstract Syntax Transfer Syntax Role Ext. Neg. Name UID Name UID Spatial Registration Storage RT Structure Set Storage RT Image Storage CT Image Storage Implicit VR Little Endian Implicit VR Big Endian Explicit VR Big Endian Implicit VR Little Endian Implicit VR Big Endian Explicit VR Big Endian Implicit VR Little Endian Implicit VR Big Endian Explicit VR Big Endian Implicit VR Little Endian Implicit VR Big Endian Explicit VR Big Endian SCU None SCU None SCU None SCU None SOP-Specific Conformance for All Storage SOP Classes The C-STORE response status-handling behavior of the PTI client Storage SCU upon storage is summarized in the table below. Service Status Further Meaning Error Code Behavior Refused Out of Resources A7xx The user is informed that the C-STORE Failure Data Set does not A9xx request has failed. Status Comment match SOP Class (0000,0902) is logged and displayed along with additional error information. Cannot understand Cxxx Warning Coercion of Data Elements Data Set does not match SOP Class Elements Discarded B000 B007 B006 The SCP has successfully stored the SOP Instance. Because a warning status was received Status Comment (0000,0902) is logged. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

18 2 Networking Service Status Further Meaning Error Code Behavior Success Success 0000 The SCP has successfully stored the SOP Instance. No user feedback is received. * * any other status code Depending on the type of the Error Code it is either handled like a Failure or Warning. However, Error Codes other than listed above in this table should not occur, as they are not defined for C- STORE (see [1] [} Page: 10], PS 3.4, Table B.2-1). After sending all SOP Instances, either successfully or not, the Association is released using A-RELEASE, and the results are presented to the user. PTI client Storage SCU communication failure behavior is listed in the table below. Exception Timeout Association aborted by the SCP or network layers Behavior The Association is released using A-RELEASE and the whole task of sending SOP Instances is aborted. The user is informed about the timeout and available information about it is logged. The whole task of sending SOP Instances is aborted. The user is informed about the aborted associations and available information about it is logged. SOP-Specific Conformance for RT Structure Set Storage Detected marker positions will be saved to a new structure set. This structure set references the planning CT Frame of Reference and contains the detected marker positions as they are projected on the planning CT. The modified structure set gets a new UID and the private referenced structure set sequence (3263,1001) is used to denote the original structure set (with the old UID). This sequence maybe used by the Treatment Management System to combine the new structure set and the original one to add the markers as detected by ProBeam Imaging. The ROI Contour Sequence (3006, 0040) shall have the following definitions: Contour Geometric type (3006, 0042) = POINT Number of Contour Points (3006, 0046) = 1 The ROI observation module shall have the following definitions: RT ROI Interpreted Type (3006,00A4) = MARKER Marker position may be located between slice positions. Before exporting modified volumetric structures, they get resampled onto the planes of the 3D patient model. The volumetric ROI Contours of an exported RT Structure Set will thus always reference an image slice. All images used to construct the 3D patient model are referenced in Contour Image Sequence (3006,0016) of RT Structure Set Module, even if they do not have any contours defined on them. 18/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

19 2.2 AE Specifications SOP-Specific Conformance for Spatial Registration Storage If the application is configured to store spatial registration IODs according to the IHE Radiation Oncology format, then spatial registration storage complies to IHE- RO_MMRO-II Supplement (see [4] [} Page: 10]). Otherwise, the following SOP-specific conformance applies: The spatial registration of the 3D/3D Match will be used in the following way: The Frame of Reference module of the spatial registration will belong to the Frame of Reference of the acquired verification CT image slices. The transformation matrix type will be RIGID. The spatial registration of the 2D/3D Match will be used in the following way: The Frame of Reference module of the spatial registration will belong to the Frame of Reference of the acquired verification RT images. The transformation matrix type will be RIGID. The spatial registration of the Marker Match will be used in the following way: The Frame of Reference module of the spatial registration will belong to the Frame of Reference of the acquired verification RT images. The transformation matrix type will be RIGID Activity Query/Retrieve Description and Sequencing of Activities This function is typically performed by the application to load the reference images and to load the reference CT and its structure set. At this time, an association is requested. This application supports Query/Retrieve in the SCU role. The table below shows the supported values for the tag Query/Retrieve Level (0008,0052). Query/Retrieve Level Value in (0008,0052) Composite Object Instance Information IMAGE Proposed Presentation Contexts The PTI client Q/R SCU Application Entity is capable of proposing the presentation contexts shown in the table below. Presentation Context Table Abstract Syntax Transfer Syntax Role Ext. Neg. Name UID Name UID Study Root Query/ Retrieve information model FIND DICOM Implicit VR Little Endian SCU None 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

20 2 Networking Presentation Context Table Abstract Syntax Transfer Syntax Role Ext. Neg. Name UID Name UID Study Root Query/ Retrieve information model MOVE DICOM Implicit VR Little Endian SCU None SOP-Specific Conformance for C-MOVE SOP Classes The behavior of the PTI client Query/Retrieve SCU when encountering status codes in a C-MOVE response is summarized in the table below. Service Status Further Meaning Refused Out of Resources Unable to calculate number of matches Failure Cancel Warning Success Pending Out of Resources Unable to perform sub-operations Move Destination unknown Identifier does not match SOP Class Unable to Process Sub-operations terminated due to Cancel Indication Sub-operations complete One or more Failures Sub-operations complete No Failures Sub-operations are continuing Error Code A701 A702 A801 A900 Cxxx FE00 B000 Behavior None of the requested SOP Instances could be retrieved. The user will be informed about the failure. Cancel is handled like Failure. Some or all SOP Instances have not been transmitted successfully. The user is informed All SOP Instances have successfully been transmitted. FF00 * * Any other status code. Transferring requested SOP Instances is continuing. This message is ignored. Any other status code is handled like Failure. After having received all requested SOP Instances, or when the user aborts the operation, the Association is released using A-RELEASE. All events occurring during querying and retrieving SOP Instances are logged. If any log entries are marked with the internal category Error, they are shown to the user automatically. No C-CANCEL-MOVE requests are ever issued. PTI Q/R C-MOVE SCU communication failure behavior is shown in the table below. 20/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

21 2.2 AE Specifications Exception Timeout Association aborted by the SCP or network layers Behavior The user is informed that the operation has timed out. The user is informed when the association is aborted during a C- MOVE operation. The attributes that are sent by the C-MOVE SCU are listed in the table below. Name Tag VR Type Query/Retrieve Level (0008,0052) CS R SOP Instance UID (0008,0018) UI U Study Instance UID (0020,000D) UI U Series Instance UID (0020,000E) UI U The values in the Type column in the above table should be read as follows: U - Universal Matching R - Range Matching One or more matching types of the above list can be supported per attribute. Operations This application performs only the operations listed in the table below. This table also shows which of the key values (see Digital Imaging and Communications in Medicine (DICOM)) are used for a request. Operation Target IOD Key Value Used for Request C-MOVE RT Structure Set SOP Instance UID C-MOVE RT Ion Plan SOP Instance UID C-MOVE RT Image SOP Instance UID C-MOVE CT Image SOP Instance UID Association Acceptance Policy The ProBeam Imaging Client Application Entity does accept storage requests for those objects requested by the MOVE SCU Activity Receive Storage Request Description and Sequencing of Activities Received SOP Instances are received and cached on the file system, as well as being passed to the application. General Preconditions ProBeam Imaging supports only ad-hoc imaging. Setup fields in the RT Ion plan are ignored. If the plan contains treatment beams having different isocenters, the couch shift found by the image-guided patient positioning is only applied to treatment beams/ isocenters that are within a given distance to the active treatment beam/isocenter. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

22 2 Networking That distance is user configurable and is controlled by the Proton Treatment Console (see [2] [} Page: 10]). Preconditions for reference CT Images To load the slices of the reference CT image ProBeam Imaging loads the plan s structure set, which corresponds to the Referenced RT Structure Set (300C,0060), from the Treatment Management System, and subsequently loads all CT slices referenced in the Contour Image Sequence (3006,0016). Conditions for CT Slices: All CT slices shall have the same Frame of Reference. The spacing between CT slices positions in z-direction (DICOM Patient coordinate system) may vary, although it is recommended, that they are equal throughout all slices referenced by the Structure Set. The maximal difference in x-direction and in y-direction (DICOM Patient coordinate system) between all CT slices shall be less or equal 0.1 mm. Conditions for Structure Set (except Structures of Contour Geometric type (3006, 0042) POINT): The contour points within a contour shall be positioned on the same contour plane within a maximal Epsilon of 10-6 in z direction (DICOM Patient coordinate system). Structures with contour(s) having contour points that are not positioned on the same contour plane (see point above, i.e. non-transversal structures) are ignored (they are not imported and a corresponding warning message is issued) and the import will continue with the other structures. Contour Geometric Type (3006, 0042) has to be either CLOSED_PLANAR or OPEN_PLANAR for all contours of the structure. Structures with mixed contour types are not supported. Contour Geometric type (3006, 0042) POINT doesn't need to fulfill the conditions mentioned above. Preconditions for 2D/3D Match Besides the General Preconditions, the following condition shall be fulfilled: Two images, one from each kv system, are required. To load the slices of the reference CT image the conditions listed in paragraph [} Page: 22] apply. Preconditions for Marker Match Besides the General Preconditions, the following condition shall be fulfilled: A delta of 45.0 degrees between the gantry/source angles (300A,011E) of the two acquired images is required. To load the slices of the reference CT image the conditions listed in paragraph [} Page: 22] apply. Conditions for Marker Point Structures: 22/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

23 2.2 AE Specifications The markers shall be in the structure set referenced by the plan. Marker position may be located between slice positions. The ROI Contour Sequence (3006, 0040) shall have the following definitions: Contour Geometric type (3006, 0042) = POINT Number of Contour Points (3006, 0046) = 1 The ROI observation module shall have the following definitions: RT ROI Interpreted Type (3006,00A4) = MARKER. Private tag: Marker Subtype (3271,1000) = MARKER Preconditions for 3D/3D Match Besides the General Preconditions, the following condition shall be fulfilled: To load the slices of the reference CT image the conditions listed in paragraph [} Page: 22] apply. Accepted Presentation Contexts ProBeam Imaging Client Storage SCP Application Entity accepts Presentation Contexts shown in the following table. Presentation Context Table Abstract Syntax Transfer Syntax Role Ext. Neg. Name UID Name UID All Storage SOP Classes in Table 4-1 All Storage SOP Classes in Table 4-1 DICOM Implicit VR Little Endian DICOM Explicit VR Little Endian SCP None Table 2 14 Acceptable Presentation Contexts for ProBeam Imaging Client Storage SCP Application Entity and Receive Storage Request SOP Specific Conformance for all Storage SOP Classes Presentation Context Acceptance Criterion ProBeam Imaging Client Storage SCP will always accept any Presentation Context for the supported SOP Classes with the supported Transfer Syntaxes. More than one proposed Presentation Context will be accepted for the same Abstract Syntax if the Transfer Syntax is supported, whether or not it is the same as another Presentation Context. Transfer Syntax Selection Policies If offered a choice of Transfer Syntaxes in a Presentation Context, ProBeam Imaging Client Storage SCP will select the first Transfer Syntax that is listed in the Presentation Context. ProBeam Imaging Client Storage SCP will accept duplicate Presentation Contexts, that is, if it is offered multiple Presentation Contexts, each of which offers acceptable Transfer Syntaxes, it will accept all Presentation Contexts, applying the same rule for selecting a Transfer Syntax for each as described above. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

24 2 Networking Response Status ProBeam Imaging Client Storage SCP will behave as described in the Table below when generating the C-STORE response command message. Service Status Further Meaning Error Code Behavior Refused Out of Resources A700 Failed to receive incoming DICOM Out of Resources A7xx Stream. Problem is logged on the SCP side. Failure Invalid object instance 0117 Warning Data Set does not match SOP Class Invalid C-STORE request Coercion of Data Elements Data Set does not match SOP Class Elements Discarded A9xx C000 B000 B007 B006 Image successfully stored in temporary file. Success 0000 Instance successfully stored in temporary file. Table 2 15 Response Status of ProBeam Imaging Client Storage SCP and Receive Storage Request 2.3 Network Interfaces See Varian System Server DICOM Conformance Statement. 2.4 Configuration AE Title/Presentation Address Mapping Local AE Titles The local PTI client Application Entity uses the AE Title and TCP/IP port number configured via the treatment daemon configuration tool. Note that conceptually, the network services have been modeled as separate AEs, though in fact all the AEs share a single (configurable) AE Title. Application Entity Default AE Title Default TCP/IP Port PTI Application Entity PTImageClient (configurable) (configurable) PTI Storage SCU See above See above PTI Query/Retrieve SCU See above See above 24/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

25 2.4 Configuration Remote AE Title/Presentation Address Mapping PTI Client Storage SCU For the PTI client Storage SCU, the TCP/IP address, called AE title, and port number of the destination are configurable as well as the calling AE title used by PTI. PTI Client Query/Retrieve SCU For the PTI client Query/Retrieve SCU, the TCP/IP address, called AE title, and port number of the provider are configurable. The calling AE title of the local application, which is also the Move Destination AE title, is configurable, too. The local port is the port of the Storage SCP for receiving the data. The Storage SCP accepts only connection requests from the configured remote AE title and IP address Parameters The table below shows DICOM-relevant configuration parameters. While some of them can be configured directly via a configuration dialog or a configuration application, other values can either be accessed only via the Registry or cannot be configured at all. Parameter General Parameters Configurable (Yes/No) Default Value Max PDU Receive Size No Unlimited Max PDU Send Size No Bytes (32kB) Time-out waiting for an acceptance or rejection response to an Association request or Association Release request (Application Level Timeout) Spatial Registration formatted along IHE-RO specification 2008 No No 300s Yes ProBeam Imaging Client Storage SCU Specific Parameters ProBeam Imaging Client Query/Retrieve SCU Specific Parameters Time-out awaiting a Response to a DIMSE Request (Low-Level Timeout) Maximum number of simultaneously initiated Associations No No 3 300s 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

26 3 Media Interchange 3 Media Interchange The PTI client Application Entity allows importing and exporting of DICOM media files. Various import and export filters are available in the PTI client application to read and create DICOM media files. This functionality is available only when the PTI application is operating in file mode. The files conform to the Part 10 format; however, the Basic Directory IOD as defined in Media Interchange Application Profiles is not present. The table below shows transfer syntaxes used in DICOM media files created by ProBeam. The transfer syntax to be used for writing a file is selected automatically based on the IOD s content (see row labeled Context of Usage ). Context of Usage Transfer Syntax IOD Name UID All IODs DICOM Implicit VR Little Endian /80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

27 4 Support of Character Sets No support for character sets beyond the Default Character Repertoire is available. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

28 5 Security 5 Security 5.1 Security Profiles No security profiles are supported. 5.2 Association Level Security The Storage SCU does not support association level security. The Storage SCP instantiated to receive Instances requested by the Query/Retrieve SCU checks the following additional values when determining whether to accept association open requests: Called AE Title Calling AE Title IP address of Association Request originator The treatment daemon Application Entity checks the following values when determining whether to accept association open requests: Implementation Class UID 5.3 Application Level Security To load patient information into the Proton Therapy Imaging application, the user opens the patient in the treatment application, which requires user identification in the form of a user name and password. 28/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016

29 Appendix A - Specialization A.1 IOD Contents A.1.1 Created SOP Instances IODs created by the ProBeam Imaging Application Entity are listed in Appendix B - IOD Details. A.1.2 Usage of Attributes from Received IODs The PTI Application Entity requires all Type 1 attributes to be present. A.2 Data Dictionary of Private Attributes The PTI application does not use any private attributes that are not described in this document or in Varian System Server DICOM Conformance Statement. A.3 Coded Terminology and Templates A.3.1 Context Groups Information on context groups can be found in Varian System Server DICOM Conformance Statement. A.3.2 Template Specifications No standard templates are extended and no private templates are used. A.3.3 Private Code Definitions There are no private code definitions. A.4 Grayscale Image Consistency. A.5 Standard Extended/Specialized/Private SOP Classes Not used. A.6 Private Transfer Syntaxes No private transfer syntaxes are used. 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80

30 30/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016 Appendix B - IOD Details B.1 IODs For better correlation with the DICOM Standard, the subsection headings in this section include the corresponding section in the DICOM Standard. B.1.1 Computed Tomography Image A.3.3 IE Module Reference DICOM Usage Support Patient Patient C M Patient Clinical Trial Subject C U Study General Study C M Study Patient Study C U Study Clinical Trial Study C U Series General Series C M Series Clinical Trial Series C U Frame of Reference Frame of Reference C M Equipment General Equipment C M Image General Image C M Image Image Plane C M Image Image Pixel C M Image Contrast/Bolus C C Image Device C U Image Specimen C U Image CT Image C M Image Overlay Plane C.9.2 U Image VOI LUT C.11.2 U Image SOP Common C.12.1 M B.1 IODs

31 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80 IE Module Reference DICOM Usage Support Image Common Instance Reference C.12.2 U B.1.2 Spatial Registration A IE Module Reference DICOM Usage Support Patient Patient C M Patient Clinical Trial Subject C U Study General Study C M Study Patient Study C U Study Clinical Trial Study C U Series General Series C M Series Clinical Trial Series C U Series Spatial Registration Series C.20.1 M Frame of Reference Frame of Reference C M Equipment General Equipment C M Spatial Registration Spatial Registration C.20.2 M Spatial Registration Common Instance Reference C.12.2 M Spatial Registration SOP Common C.12.1 M B.1.3 RT Structure Set A.19.3 IE Module Reference DICOM Usage Support Patient Patient C M Patient Clinical Trial Subject C U Study General Study C M Study Patient Study C U Study Clinical Trial Study C U Series RT Series C M Series Clinical Trial Series C U Appendix B - IOD Details

32 32/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016 IE Module Reference DICOM Usage Support Equipment General Equipment C M Structure Set Structure Set C M Structure Set ROI Contour C M Structure Set RT ROI Observations C M Structure Set Approval C U Structure Set SOP Common C.12.1 M Structure Set Common Instance Reference C.12.2 U B.1.4 RT Image A.17.3 IE Module Reference DICOM Usage Support Patient Patient C M Patient Clinical Trial Subject C U Study General Study C M Study Patient Study C U Study Clinical Trial Study C U Series RT Series C M Series Clinical Trial Series C U Frame of Reference Frame of Reference C U and required for Import Equipment General Equipment C M Image General Image C M Image Image Pixel C M Image Contrast/Bolus C C Image Cine C C Image Multi Frame C C Image Device C U Image RT Image C M B.1 IODs

33 21-Nov-2016 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR /80 IE Module Reference DICOM Usage Support Image Modality LUT C.11.1 U Image VOI LUT C.11.2 U Image Approval C U Image Curve (Retired) C.10.2 U Image SOP Common C.12.1 M Image Common Instance Reference C.12.2 U Image Frame Extraction C.12.3 C Extended Interface Extended Interface N/A U Private B.2 Modules and Attributes For better correlation with the DICOM Standard, the subsection headings in this section include the corresponding section in the DICOM Standard. The first four columns in the following tables contain definitions from the DICOM standard. References in those columns refer to the DI- COM standard and not to this document. The Handling column describes for each attribute whether it is supported and the value in the ProBeam Imaging system to which it maps. A value of "Not indicates that an attribute is unknown and therefore ignored by the application. The application creates objects of the types RT Image, CT Image, RT Structure Set, and Spatial Registration. These objects are exported through DICOM; therefore, only the export is described in the tables. B.2.1 Patient C Patient s Name (0010,0010) 2 Patient's full name. Patient ID (0010,0020) 2 Primary hospital identification number or code for the patient. Issuer of Patient ID (0010,0021) 3 Identifier of the Assigning Authority that issued the Patient ID. Patient's Birth Date (0010,0030) 2 Birth date of the patient. Appendix B - IOD Details

34 34/80 DICOM Conformance Statement: Proton Therapy Imaging/PB-CTR Nov-2016 Patient's Sex (0010,0040) 2 Sex of the named patient. Enumerated Values: M = male F = female O = other Referenced Patient Sequence (0008,1120) 3 A sequence that provides reference to a Patient SOP Class/Instance pair. Only a single Item shall be permitted in this Sequence. > Content of not supported sequence is not listed. Export: Female : F, Male : M, anything else: O Patient's Birth Time (0010,0032) 3 Birth time of the Patient. Other Patient IDs (0010,1000) 3 Other identification numbers or codes used to identify the patient. Other Patient Names (0010,1001) 3 Other names used to identify the patient. Ethnic Group (0010,2160) 3 Ethnic group or race of the patient. Patient Comments (0010,4000) 3 User-defined additional information about the patient. Patient Identify Removed (0012,0062) 3 The true identity of the patient has been removed from the Attributes and the Pixel Data Enumerated Values: YES NO De-identification Method (0012,0063) 1C A description or label of the mechanism or method use to remove the patient's identity. May be multi-valued if successive de-identification steps have been performed. Note: This may be used to describe the extent or thoroughness of the de- identification, for example whether or not the de-identification is for a "Limited Data Set" (as per HIPAA Privacy Rule). Required if Patient Identity Removed (0012,0062) is present and has a value of YES and De-identification Method Code Sequence (0012,0064) is not present. B.2 Modules and Attributes