DICOM � A Preclinical Perspective by gbZk9SD

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									DICOM – A Preclinical Perspective



AK Narayan, Kishan Harwalkar, Kshitija Thakar
Philips Healthcare,

April 09, 2008
 Agenda
  Introduction to Preclinical
  IMALYTICS Workspace
  Information Model Requirements
  Mapping to DICOM
  DICOM Constraints on Preclinical
  Challenges and Future Work
  Conclusions




CONFIDENTIAL                     Philips Healthcare, Apr 09, 2008   2
 Research Workflow
  Research is characterized by exploratory and/or hypothesis-driven
 programs often supported by grants to either discover or explore new
 insights into biological processes.

  The systematic discovery and development of biomarkers, drugs, and
 therapies that will ultimately be translated from animal models to human
 should they prove promising during preclinical studies.



    Exploratory                     Statistically                  Enabled by
    or Hypothesis   Transition to   Significant                    Pre-Clinical
    driven               ...        Results                        Workspace




CONFIDENTIAL                              Philips Healthcare, Apr 09, 2008        3
  Preclinical Imaging
    “Researchers are not mouse doctors”




        Fundamental                          Design and
                                                                                     Test Bed for new
        Understanding                     Evaluation of new
                                                                                         Imaging
          of Biology/                    Biomarkers (drugs)
                                                                                       Technologies
         Biochemistry                    (diagnosis/therapy)

   • transfer in-vitro               • dynamics and kinetics                      • small size prototypes
     to in-vivo                      • efficacy (candidate                        • low capital investment
   • verify models                     selection)                                 • POC (proof of concept)
                                     • dosing
   Massoud T.F., Gambhir S.S.;        Rudin M., Weissleder R.;                     Gleich B., Weizenecker J.;
   Molecular Imaging in living        Molecular Imaging in drug                    Tomographic Imaging using
   subjects: seeing fundamental       discovery and development                    the nonlinear response of
   biological processes in a new      Nat. Rev. Drug Discov., 2, 123-              magnetic particles
   light; Genes Dev., 17, 545-580,    131, 2003                                    Nat., 435(30), 1214-1217, 2005
   2003


CONFIDENTIAL                                   Philips Healthcare, Apr 09, 2008                                     4
  Imaging applications in drug discovery
  and development




      Rudin M., Weissleder R.;
      Molecular Imaging in drug discovery and development
      Nat. Rev. Drug Discov., 2, 123-131, 2003

CONFIDENTIAL                        Philips Healthcare, Apr 09, 2008   5
 Multi-modality in Preclinical




               Massoud & Gambhir, Genes & Development, 2003

CONFIDENTIAL                     Philips Healthcare, Apr 09, 2008   6
  Preclinical application needs
   Increasing the productivity, reproducibility, and standardization of a
   variety of experimental approaches such as:
         – Snapshot measurement on a single subject

         – Longitudinal studies on the single subject across multiple

               sessions

         – Group studies on multiple subjects in the same laboratory

         – Studies on distributed population groups that are done to

               substantiate the hypothesis.




CONFIDENTIAL                          Philips Healthcare, Apr 09, 2008      7
 IMALYTICS Workspace

   Multi-modality Preclinical Workstation

   Provides a combined view of the different facets of the drug discovery
  process.

   Provides advanced image analysis, quantification, and visualization
  tools dedicated to research and discovery




CONFIDENTIAL                    Philips Healthcare, Apr 09, 2008             8
 IMALYTICS Modeling requirements
  Data Mining
       – Project Oriented View
       – Each Preclinical Project will involve multiple Subjects with Series of
         images under each

  Interoperability
       – High Interoperability with existing Standards
       – High Interoperability with existing Preclinical data

  Compatibility
       – Extendable for Clinical Trials
       – Compatible with existing Clinical Apps




CONFIDENTIAL                       Philips Healthcare, Apr 09, 2008               9
 Preclinical Real-World Model
               Project
    Project ID
    Description
    Principal Investigator

                                                                1..n
                   1..n

               Subject                                  Series
    Subject ID                            Series Number
    Strain Name                           Modality
    Sex                                   Series Description


                   1..n                                         1..n        1..n

               Study                                    Image              Non Image
    Study ID
    Study Date                            SOP Common Module
                                                                       SOP Common Module
                                          Image Pixel Module




CONFIDENTIAL                 Philips Healthcare, Apr 09, 2008                              10
  DICOM Clinical Trial Model
                       Patient                                           Clinical Trial Subject
               Patient ID                                1..n       Clinical Trial Sponsor Name
               Patient Name                                         Clinical Trial Protocol Name
               Patient Sex                                          Clinical Trial Protocol ID


                               1..n

                        Study
               Study ID
               Study Date



                               1..n

                       Series                                                         1..n
               Series Number
               Modality                                                          Image
               Series Description
                                                                          SOP Common Module
                                                                          Image Pixel Module




CONFIDENTIAL                          Philips Healthcare, Apr 09, 2008                             11
 Mapping Preclinical Model to DICOM
    Patient                             Project
                                                                              Depicts the Conceptual
                                                                               Model of the Preclinical
                                                                               domain
               Clinical Trial Subject
                                        Subject
                                                                              Data mining at Project Level
                                                                               would be easy
     Study

                                        Study
                                                                              Less Compatibility with
                                                                               existing clinical applications

    Series                              Series
                                                                              Low Interoperability with
                                                                               clinical DICOM data

    Image
                                        Image

CONFIDENTIAL                            Philips Healthcare, Apr 09, 2008                                        12
 Mapping Preclinical Model to DICOM
    Patient                             Project
                                                                              High co-relation with DICOM
                                                                               Model
               Clinical Trial Subject

                                        Subject
                                                                              High Compatibility with
                                                                               existing Clinical Applications

     Study

                                        Study
                                                                              High Interoperability




    Series                              Series
                                                                              Differs from the Conceptual
                                                                               Preclinical model



    Image
                                        Image
                                                                              Data mining at Project level
                                                                               is not easy


CONFIDENTIAL                            Philips Healthcare, Apr 09, 2008                                        13
  IMALYTICS Model
    Patient                             Project                            Interoperability :
                                                                            Easily achievable

               Clinical Trial Subject                                      Compatibility :
                                        Subject                             Can be used for Clinical Trial
                                                                            Clinical Apps can be easily
     Study                                                                   integrated

                                        Study                              Data Mining :
                                                                            Not possible via the Model
                                                                            Can be achieved via Software
    Series                              Series                             Semantic Correlation :
                                                                            High Correlation with DICOM

    Image
                                        Image

CONFIDENTIAL                            Philips Healthcare, Apr 09, 2008                                      14
 Project-oriented Workflow
                                                       Enables Project Oriented
                                                        View with local Database



                                                       The Project Oriented view
                                                        can be seamlessly used for
                                                        Clinical Trials


                                                       Project Oriented View may
                                                        not be possible with DICOM
                                                        Network and Media



                                                       Importing a Complete
                                                        Project in one shot is not
                                                        possible


CONFIDENTIAL     Philips Healthcare, Apr 09, 2008                                    15
 DICOM Constraints on Preclinical
                                     Group Studies

                                           Multiple Subjects are a part of the
                                           same Scan

                                               – Sharing the same Study after
                                                 splitting into multiple
                                                 hierarchy is not possible
                                               – Orientation of individual
                                                 subject can not be
                                                 represented




CONFIDENTIAL     Philips Healthcare, Apr 09, 2008                            16
 DICOM Constraints on Preclinical

  DICOM Type 2 attributes may not always be applicable in the
   Preclinical domain

       – Patient Birth Date

       – Patient Sex

       – Referring Physician




CONFIDENTIAL                   Philips Healthcare, Apr 09, 2008   17
 Challenges and Future Work
 • Challenges
       – IMALYTICS Model vs. Preclinical model by other vendors
       – Non availability of Data from different vendors
       – Non availability of DICOM Conformance Statements for preclinical
           products


 • Future Work
       – Extending the IMALYTICS model for Group Studies
       – Applicability of the current model for
               • Distributed population Study
               • Clinical Trials
       – Dealing with non-image data like Histology (in-silico, in-vitro, ex-
         vivo)

CONFIDENTIAL                           Philips Healthcare, Apr 09, 2008         18
 Conclusions
  Preclinical Imaging has emerged recently as a powerful tool that
   enables Clinical Research

  Going forward Interoperability would be the key in Preclinical domain
   (especially for translational research)

  Specific platforms to address Interoperability in Preclinical
   (IHE/Connectathon) are required




CONFIDENTIAL                     Philips Healthcare, Apr 09, 2008          19

								
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