Anthony M. Levering Assistant Director, Core lab

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

2. Lead Tech Supporting Tech Communication is Key Institution Principal Investigator ACRIN Treatment Arm Imaging Arm ? ? ? Radiologist RA

4. Are Radiology department staff engaged? • Technologists? • Radiologists? • Physicists?

5. 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

6. What is CQIE qualifying? • 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

7. 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”

8. 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

9. 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.

10. Assuring Quality • 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

11. DICOM Meta-data • 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

12. 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

13. 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.

14. Suggested Solutions • 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

15. Compliance - Like magic!