Medical Image Database Resource for Software Tools Evaluation and MIRC

1. Medical Image Database Resource for Software Tools Evaluation and MIRC Laurence P Clarke, PhD Barbara Croft PhD Carl Jaffe MD Gary Becker MD Dan Sullivan MD Cancer Imaging Program

2. Resource for Benchmarking Application Specific Software Performance. • Need to develop a consensus or standards for assessment of application specific software for cancer imaging. • Software methods and related informatics tools lag behind the front end imaging technology in terms of their performance (MRI,CT, Molecular Imaging..). • Need to engage the national and international community in the development and assessment of advanced software tools. • Need to explore if this resource could be employed to reduce delay or uncertainty in FDA approval. • Need to develop IT resource to establish this database and provide web access to this resource to encourage standards for software assessment.

3. Example Projects: Evaluation of Software Tools as required Lung Cancer using X-ray CT. • Lung Image Database Consortium (LIDC): Database to permit the benchmarking of CAD methods for cancer screening. • Lung Database for Drug Response. Database to permit the benchmarking of software metrics such as volumetric measures of tumor response to drug or radiation therapy.

4. U01: Lung Image Database Consortium (LIDC) (U01: 2001-2006): • NCI: ACRIN/NLST (2002-2008: $200M/9 years) is supporting a large lung cancer screening trial using helical CT, where subsets of images can be collected. • LIDC ($7M/5 years: 5 Academic Sites). Goals: Develop an image database for the comparison of CAD methods, and encourage standards for assessment of application-specific software. • LIDC Steering Committee: Includes academic members from each site, FDA CDRH scientists and consultants that are engaged in the developing broad understanding of all the issues involved in the development of a public database, as a transparent process.

5. Foundation for NIH: Facilitate Public Private Partnerships • Authorized by Congress in 1991--and established in 1996-- to support the NIH in its mission through collaboration with academia, industry, individuals, and other non-profits. • An independent non-profit, not a government organization. • Governed by independent Board of Directors, including the Director of NIH and the FDA Commissioner as ex-officio members.

6. Partnership ModelBased on the Osteoarthritis Initiative $$Flow Private Partners InformationFlow Steering Committee FNIH FDA NIH Grants or Contracts

7. FNIH-NCI Plans (2005-06): Expand the proposed databases as an industry resource • Form an overarching steering committee with FNIH, NCI, Academic and Industry representation • Identify specific milestones for early delivery of databases acquired from NCI clinical trails. • Lung Cancer Screening: Expand the number of sites for X-ray CT include digital chest X ray (Jan 2005) • Lung Cancer Drug Response: X-ray CT. Expand Pilot Project (Sept 2004): PPP timetable: Summer Fall 2005

8. The Database Resource Research Community MIRC sites: • NCI • FDA CDRH • Cornell University • MD Anderson Cancer Center • Memorial Sloan Kettering Cancer Center • University of California, Los Angeles • University of Chicago • University of Iowa • University of Michigan… • Industry Partners

9. Meta Data: Results of Unblinded Reads: Nodule Location 4/4 Markings 2/4 Markings 2/4 Markings We will capture one aspect of reader variability in this way

10. Nodules ( ) Focal Abnormalities Metadata: Description of Nodule • A spectrum of abnormalities? Calcified Nodule Spiculated Nodule Scar

11. Meta Data: Nodule Characteristics Library to Standardize Radiologist Interpretation.

12. Meta Data: Nodule Boundaries Example Spiculated Nodule: Comparison of Contours

13. Meta Data: Probabilistic Description of Boundary

14. RSNA: 2003:LIDC: Fundamental Issues for the Creation of a International Research Resource for the Image Informatics Community.

15. NCI Current and Future Clinical Trials.Potential Sources of Data and Timeline Demonstration Project: LIDC Lung Drug Response: Pilot Project Enhance hardware and software infrastructure with NCICB Enhance hardware and software infrastructure with NCICB Digital breast- ACRIN Digital breast- ACRIN PET alliances Liver mets - MSK Liver mets - MSK Colonoscopy collection ACRIN Colonoscopy collection ACRIN MRI - ACRIN MRI - ACRIN Ultrasound Ultrasound Colonoscopy collection - Navy NTROI optical database NTROI optical database Year 1 Year 2 Year 3

16. Meta Data: NCI Informatics Infrastructure Planned Reference Database Resource to be Fully Integrated into caBIG Informatics GRID. accessportals participatinggroup nodes ClinicalTrials MolecularSignatures NCI Core TGI CancerGenomics MouseModels GAI CCAP GRID Principles • Open source • Open access • Open development • Federated Group Nodes: Cancer Centers SPORES CGAP MMHCC Others

17. Users Database Resource NCI and FDA Cornell MIRC Site MDA Internet MSK PACS UCLA Chicago n Iowa Work-stations Mich. MIRC sites

18. Database Resource Several Demonstration Projects 2005-06 PACS DICOM MIRC Clinical Trial Service MIRC Clinical Trial Service Modality (images) DICOM 8443 HTTP(S) 8080 CTMS (csv data) HTTP MIRC Storage MIRC Storage Field Center Sites Principal Investigator Site Required extensions: 1. image export in groups 2. CSV converter to metadata for NID Desirable extensions: 1. name spaces 2. cde viewing / query 3. extend author service