1. The Quantitative Imaging Network (QIN) Robert Nordstrom, Ph.D. Larry Clarke, Ph.D.

2. QIN: A CIP/RRP Initiative Quantitative Imaging for Evaluation of Response to Cancer Therapies U01: –Quantitative Imaging Network (QIN) Support multi-disciplinary research teams to develop quantitative imaging methods to measure response to therapy. Optimization and validation of data collection & analysis methods in ongoing clinical trials. Commercial imaging platforms. Provide image meta-data, clinical outcome data, and measurement results as a public resource. Phantoms for quality assurance & control. http://grants.nih.gov/grants/guide/pa-files/PAR-08-225.html

3. Purpose of the QIN Program Our hypothesis: Optimized and validated quantitative imaging techniques are needed on commercial platforms for large scale multi-center clinical trials focused on therapy response. Therefore: Necessary to promote innovative research in this area. Goal: Bring quantitative imaging as a validated method or tool to oncologists for clinical decision making.

4. Deliverables in the QIN Program Understand and overcome physical and biological measurement uncertainties. Eliminate or minimize qualitative and observer- based estimates of measurements of therapy response. Create clinical decision tools that are reliable over multiple sites and commercial devices. Database development and informatics.

5. The QIN Program Builds from a successful RIDER (Reference Image Database to Evaluate Response) program. –NCI web-based public resource –Lung and other organ sites images and metadata –Phantom data, quality assurance

6. The Quantitative Imaging Network (QIN) PAR-08-225; a U01 mechanism issued August 2008 –No set-aside funds and no limit to the number of awards Submission dates: –February 5, June 5, and October 5 –Paper submissions Reviewed by Special Emphasis Panel (SEP) from NCI

7. The “Model” Program A QIN Member Annotated database with metadata & outcomes Clinical trial Data & Results An Appropriate Clinical Trial Validation Development

8. Clinical Trials Ongoing or planned trials must be identified: Trials not supported by QIN Phase I,II, and/or III QIN will support additional images beyond trial protocol (IRB approval) QIN will support correlative studies such as genomics ACRIN is an obvious source for the trials

9. Early-Stage QIN & ACRIN Interaction A Progressing ACRIN Clinical Trial A QIN Member Link to trial Image data are received

10. QIN & ACRIN Interaction The ACRIN trial must be relevant to the cancer problem of the QIN member. An ideal way to link QIN and ACRIN –ACRIN investigators apply to QIN and become network members.

11. An Example University of Washington: QIN –Linking to ACRIN 6687 (prostate) and ACRIN 6688 (breast) for tool development & validation –PET imaging –Focus on early drug trials (Phase I, II) –Tools developed will be applicable to larger Phase III trials –Enable clinical investigators, cooperative groups and pharma to include quantitative PET imaging biomarkers in study design and sample size.

12. Quantitative Methods Variance Reduction Validated Methods Clinical Tools ACRIN and QIN Association Imaging Dissemination Imaging Improvements Imaging Technologies Imaging Assessment ACRIN Imaging Standards PhantomsInformatics

13. Network Organization …. Steering Committee Working Groups Technical Teams Technical Advisory

14. Steering Committee Organization Organization –Two representatives from each team PI plus an alternate Only 1 vote for team –Two program staff Only 1 vote –Lead Program Director No vote –Others (non-voting) may be invited to participate, depending on the subject of the meeting. Rotating annual chair Monthly teleconference meetings Two yearly face-to-face meetings

15. Working Groups Provide “open science” means to address common issues. –e.g. Data sharing, QC issues, Clinical involvement, Informatics. –Create consensus in these areas. Network-wide groups. –Each team contributes members to each working group. A chair is chosen annually. –Will hold separate monthly meetings (autonomous). –Source for network-wide publications.

16. Working Groups Data Collection Image Analysis & Performance Metrics Bioinformatics/IT & Data Sharing Clinical Trial Design & Development Outreach: External/Industrial Relations

17. Working Groups Each working group has –Defined its mission statement –Begun creating first year goals In the future, they will –Survey all QIN teams on specific working group issues –Create consensus dialogues and documents

18. Current QIN Status Currently, 6 charter members –One more team is about to be funded –1 Face-to-face (kick-off) meeting Perhaps over 12 members by 2011 Broad range of imaging modalities –CT and PET/CT –SPECT –MRI, DCE-MRI, DW-MRI Phantom studies, quality assurance Longitudinal studies Database development and sharing

19. Who is Doing What in the QIN InstituteCancer ProblemImaging Method Other University of IowaHead & NeckPET/CTMRI/MRSIPhantoms, database Brigham & Women'sProstateMRI Moffitt Cancer CenterLungPET/CT Univ. of WashingtonBreast & ProstatePET/CT Phantoms Univ. of PittsburghHead & NeckPET/CTMRI Stanford Univ.Metastatic ColonCTMRI Vanderbilt Univ.BreastMRIPET3T

20. The Members of QIN

21. Timeline For Entry Into QIN Release date August 2008 Termination date September 2011 U. Pittsburgh Sept 1, 2009 H. Lee Moffitt CC March 9,2010 U. Iowa April 1, 2010 U. Washington April 15, 2010 Vanderbilt U. May 1, 2010 Stanford U. May 1, 2010 Brigham & Women’s September 2010 200920102011

22. Communication Within QIN Steering Committee meetings provide team-to- team communication. Regular meetings within each team provides team-to-working group communication. Chairs of working groups can participate (non- voting) in steering committee meetings. QIN Newsletter and publications

23. Associate Members to QIN Academic –Active research in quantitative imaging for cancer response –Willingness to participate in face-to-face meetings Industrial –Have products or tools of interest to QIN –Willingness to share and compare

24. The Program Team for QIN Robert Nordstrom, Lead Program Director Larry Clarke, Science Officer Gary Kelloff, Science Officer Pushpa Tandon, CIP Program Director Huiming Zhang, CIP Program Director Barbara Croft, CIP Program Director Barbara Galen, CIP Program Director James Deye, RRP Program Director