1. Imaging Core Laboratory Fall Meeting, 2011 Imaging Challenges for ACRIN sites Compliance and set-up Anthony M. Levering Assistant Director, Core lab

2. Qualifying What? Modalities Instruments Sites Acquisition Techniques Projects ACRIN XXXX Fundamental Question

3. InstitutionPrincipal Investigator ACRIN Treatment Arm Imaging Arm RA Lead Tech Supporting Tech Radiologist ??? Communication is Key

5. Are Radiology department staff engaged? Technologists? Radiologists? Physicists?

6.  Scanner capability  Supporting equipment ex: Contrast media injectors,  Staff availability, dedication and expertise  Cooperation from the Radiology department staff ex: RT, MD, RN  Research Associate Oversight of submitted data

7.  Qualify sites in the following quantitative imaging methodologies:  Volumetric CT (body), Volumetric MRI (brain)  DCE-MRI (body and brain)  Static and dynamic PET, PET-CT  (body and brain)  Provide imaging team with introduction to multicenter clinical trials What is CQIE qualifying?

8.  Standard vs. trial-specific requirements – Always require trial-specific test case  CQIE standards (QC)  How to increase protocol compliance  Distribution of scanner-specific acquisition protocols (edx files, “exam cards”

9.  Increase involvement of site technologists  Require sites to identify a “research technologist” (just like we require them to identify a research coordinator)? Imaging-centered protocol t-cons or site-specific calls? Trial-specific learning modules and/or tech documents? Offer CE credits?  Image QC: Increase “real-time” monitoring and feedback  Require first case pass QC before additional patients are scanned  Same-day QC of first 3-5 cases from every site

10.  Test exam submission regardless of prior trial qualification.  Contact information of a Radiology tech in order for the core lab to build a solid working relationship.  Timely Submission of images Allows the core lab to perform early evaluation and possibly identify potential quality issues early.  Sites under going QA submission and qualification should also be TRIAD ready before the start of the trial.

11. Importance of timely image submission by site Importance of timely quality core lab review Develop a process for handling queries Clarifications and deviations Suboptimal exams Include or not include in study Qualitative vs. Quantitative adequacy; RECIST Complex analytical expectations; Volumetric Key: Build a working relationship with participating site radiology group Assuring Quality

12.  Provide real-time compliance feedback to sites at image transfer ↑ protocol compliance  Improve technical parameters compliance QC at core lab ↑ speed and thru-put  Automate data basing of key acquisition parameters ↑ statistical review  Capture analytical outputs for ease of Tx decisions based on imaging (AIM)  Integration of imaging and clinical info DICOM Meta-data

13.  Technical parameters not followed  File format not DICOM  Required forms not submitted (ex: ITW, Technical Assessment Form)  Acquisition dates inconsistent with protocol requirements  Missing images  Artifacts  Gross Motion

14. Image Submission All images must be submitted in DICOM format. Patient identifiers must be scrubbed from the test case images before they are submitted to ACRIN. Image data should be transmitted to ACRIN electronically via secure file transfer protocol (FTP). Download and installation instructions for FTP setup are provided in the CQIE MOP (appendix A-2). If necessary, sites can ship images to ACRIN on CD- ROM.

15.  Training is paramount Site radiology staff via web conference would help to insure the protocol requirements. Incentives for site technologist for compliance and turn-around time for submissions Simulation training on the scanners (GE, Philips, Siemens) that require advanced protocol techniques. Ex: ACR training facility Suggested Solutions

16. Compliance - Like magic!