Imaging Core Laboratory Fall Meeting, 2011

Imaging Challenges for ACRIN sites Compliance and set-up

Anthony M. Levering

Assistant Director, Core lab

Institution Principal Investigator

ACRIN

Treatment Arm

Imaging Arm

RALead Tech

Supporting Tech

Radiologist

? ? ?

Communication is Key

Are Radiology department staff engaged?

Technologists?Radiologists?Physicists?

Scanner capability Supporting equipment ex: Contrast media

injectors, Staff availability, dedication and expertiseCooperation from the Radiology

department staff ex: RT, MD, RNResearch Associate Oversight of

submitted data

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?

Standard vs. trial-specific requirements – Always require trial-specific test case

CQIE standards (QC) How to increase protocol complianceDistribution of scanner-specific acquisition

protocols (edx files, “exam cards”

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

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.

Importance of timely image submission by site Importance of timely quality core lab review

Develop a process for handling queriesClarifications and deviationsSuboptimal exams

Include or not include in studyQualitative vs. Quantitative adequacy; RECISTComplex analytical expectations; Volumetric

Key:Build a working relationship with participating site radiology

group

Assuring Quality

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

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

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.

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

Compliance - Like magic!