1. DICOM Anniversary Conference Experience Using DICOM-RT Objects for Clinical Trials QA Walter R. Bosch, D.Sc., John W. Matthews, D.Sc., Vincent A. Frouhar, Ph.D., Jatinder R. Palta, Ph.D., James A. Purdy, Ph.D.

2. Bosch – DICOM Anniversary Conf. 2003 2 NCI Advanced Technology QA Consortium Members Image-guided Therapy Center (ITC) J. Purdy, W. Bosch, J. Matthews, Wm. Straube, J. Michalski Resource Center for Emerging Technologies (RCET) J. Palta, V. Frouhar, J. Dempsey Radiological Physics Center (RPC) G. Ibbott, D. Followill Radiation Therapy Oncology Group (RTOG) E. Martin, R. Lustig Quality Assurance Review Center (QARC) T.J. FitzGerald, M. Urie, K. Ulin Support NIH U24 grant CA81647, “Advanced Technology QA Center”

3. Bosch – DICOM Anniversary Conf. 2003 3 NCI Advanced-Technology QA Consortium History Created in 2002 (in its current form) by NCI to support QA for advanced technology clinical trials (P.I.: J.A. Purdy, Ph.D.) Builds on a decade of experience in supporting QA for clinical trials involving 3DCRT and IMRT Mission Develop appropriate and uniform QA procedures and criteria Facilitate sharing of developmental and QA resources for digital data submission and review

4. Bosch – DICOM Anniversary Conf. 2003 4 Dose-Response Modeling in Radiotherapy Fundamental trade-off: deliver tumoricidal dose to a target avoid injury to radiosensitive normal tissues (“organs at risk”) Normal-tissue tolerance doses in current use are based on simple point doses and do not account for dose-volume effects. Correlating volumetric doses with clinical outcomes is expected to yield better dose-response models for normal tissue.

5. Bosch – DICOM Anniversary Conf. 2003 5 Digital Data for Advanced-Technology Clinical Trials in Radiotherapy Primary data (volumetric dosimetry) Volumetric Image (CT) Structure Set: GTV, CTV, PTV, OAR 3-D Dose Distribution (including fractionation information) Secondary data (QA of primary data) Treatment Plan Specification Dose-Volume Histograms Digital Simulator and Portal Images

6. Bosch – DICOM Anniversary Conf. 2003 6 Digital Data Submission for Advanced-Technology Clinical Trials Treatment planning data are stored in proprietary formats. For meaningful exchange of information, we need a common data representation and interchange format. RTOG Data Exchange Format Based on AAPM Report 10 Used to exchange of treatment planning data in RTOG advanced technology protocols, starting in 1994. Over 1600 protocol data sets submitted to date.

7. Bosch – DICOM Anniversary Conf. 2003 7 RTOG Advanced-Technology Protocols RTOG ProtocolSiteStatus Approved Institutions Accrued Cases* 9406Prostate Ph I/IIClosed 531084 9311Lung Ph I/IIClosed 26180 9803Brain (GBM) Ph I/IIClosed 46210 H-0022Oropharynx IMRT Ph I/IIOpen 1325 H-0225Nasopharynx IMRT Ph IIOpen 132 L-0117Lung Ph I/IIOpen 3414 P-0126Prostate Ph IIIOpen 79146 P-0232Prostate Brachytherapy Ph IIIOpen 50 BR-0319Breast Ph I/IIOpen 8/15 00 * as of 9/16/2003

8. Bosch – DICOM Anniversary Conf. 2003 8 Why Use DICOM to Represent Radiotherapy Treatment Planning Information? Broadly-based industry standard Support for current and future imaging and treatment modalities PET Functional MRI External beam IMRT HDR brachytherapy Heavy-particle therapy

9. Bosch – DICOM Anniversary Conf. 2003 9 History of the DICOM RT Objects November 1994 – DICOM Ad Hoc Committee on Radiotherapy Objects met at RSNA June 1997 – Supplement 11 approved RT Structure Set RT Plan RT Dose RT Image May 1999 – Supplement 29 approved RT Treatment Record

10. Bosch – DICOM Anniversary Conf. 2003 10 DICOM RT Objects Needed for Advanced Technology Clinical Trials A participant must submit a complete, protocol- compliant data set: CT Image (MR Image, US Image), RT Structure Set, RT Dose, RT Plan, and RT Image. Many clinical implementations support only a subset of the RT objects. Typical external-beam TPS: Only recently have commercial treatment planning systems begun to export this complete set of objects. Treatment Planning System CT Image RT Structure Set RT Plan RT Image MR Image IMPORT EXPORT

11. Bosch – DICOM Anniversary Conf. 2003 11 Special Requirements for DICOM Attributes for Clinical Trials Type 3 attributes may not be present. Not meaningful in all applications Incompletely specified objects at early stages of the planning process Special requirements for attributes values, e.g., RT Plan Geometry (300A,000C) must be PATIENT. CT and MR images must have square pixels. The ATC Fileset Reader application Conformance Statement (http://itc.wustl.edu) lists required attributes and special requirements for attribute values.http://itc.wustl.edu

12. Bosch – DICOM Anniversary Conf. 2003 12 RT Dose Object Implementation Issues Single, multi-frame dose object vs. many, planar dose objects Grid Frame Offset Vector Absolute axial coordinate of dose grid plane Relative “offset” of dose grid plane from Image Position (Patient) attribute value. 32-bit Dose Values Byte-order and word-order issues

13. Bosch – DICOM Anniversary Conf. 2003 13 Maintaining Consistent Object Linkage DICOM RT objects reference each other. Structure Set references images (Frame of Reference) Plan references Structure Set References are important for automated import. Submission software should check that references are correct and complete.

14. Bosch – DICOM Anniversary Conf. 2003 14 Clinical Trials Identification Data for a clinical patient must be de-identified and associated with a clinical trial subject. DICOM Supplement 70 (Jan. 2003) introduces Clinical Trials ID modules which include 10 new attributes that can be added to any DICOM object to identify Clinical trial sponsor Clinical trial protocol Clinical trial subject

15. Bosch – DICOM Anniversary Conf. 2003 15 Submission of DICOM Data to the ATC Part-10 Filesets (currently supported) CD-R media FTP to ITC server (like RTOG Data Exchange) ATC Submission System (in development) Push DICOM data to WebSys client program (DICOM Storage SCP) on local PC Replace patient ID with clinical trials ID Perform secure upload to ATC server

16. Bosch – DICOM Anniversary Conf. 2003 16 Credentialing for Participation in Advanced Technology Clinical Trials Institutions must pass a “dry run” (benchmark) test by submitting a protocol- compliant data set to the ATC. Treatment planning systems are said to be “ATC compliant” when a complete data set received from a real, clinical user is judged to be protocol-compliant.

17. Bosch – DICOM Anniversary Conf. 2003 17 Institutions Credentialed for RTOG Protocols using DICOM RT Protocol # Institutions Credentialed* P-0232 Prostate brachytherapy5 H-0022 Head-neck IMRT1 P-0126 Prostate 3DCRT1 * as of 9/16/2003

18. Bosch – DICOM Anniversary Conf. 2003 18 ATC Efforts to Support DICOM Implementation for Clinical Trials DICOM Implementers’ Technical Workshops March 16-17, 2001 March 16, 2002 May 3, 2003 Spring 2004 Assistance in evaluating compliance of data sets Feedback to implementers via the web-based Remote Review Tool

19. Bosch – DICOM Anniversary Conf. 2003 19 Remote Review Tool CT Images (zoom, window/level) Structure contours (review, editing) Iso-dose contours Interactive DVH Point-dose display

20. Bosch – DICOM Anniversary Conf. 2003 20 Conclusions Advanced-technology clinical trials are attempting to correlate volumetric dosimetry information with clinical outcomes. Expected to yield improved dose-response models. Requires volumetric digital data The DICOM RT objects are becoming a viable option for submission of data in these studies. ATC compliant treatment planning systems are listed on the ITC website http://itc.wustl.edu. (ATC website coming in Fall, 2003.)http://itc.wustl.edu