Download Imaging Challenges for ACRIN Sites Compliance and Set-up

Imaging Challenges for ACRIN sites
Compliance and set-up
Anthony M. Levering
Assistant Director, Core lab
Imaging Core Laboratory
Fall Meeting, 2011
Communication is Key
Institution
Principal Investigator
ACRIN
Treatment
Arm
Imaging
Arm
RA
?
Radiologist
?
Lead
Tech
?
Supporting
Tech
Are Radiology department
staff engaged?
Technologists?
Radiologists?
Physicists?
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
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
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”
 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.
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
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
 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 CDROM.
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
Compliance - Like magic!