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Imaging Challenges for ACRIN sites Compliance and set-up. Anthony M. Levering Assistant Director, Core lab. Lead Tech. Supporting Tech. Communication is Key. Institution. Principal Investigator. ACRIN. Treatment Arm. Imaging Arm. ?. ?. ?. Radiologist. RA.

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anthony m levering assistant director core lab

Imaging Challenges for ACRIN sites

Compliance and set-up

Anthony M. Levering

Assistant Director, Core lab

slide2

Lead

Tech

Supporting

Tech

Communication is Key

Institution

Principal Investigator

ACRIN

Treatment

Arm

Imaging

Arm

?

?

?

Radiologist

RA

slide4
Are Radiology department staff engaged?
    • Technologists?
    • Radiologists?
    • Physicists?
slide5
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
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
slide7
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”
slide8
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
slide9
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.
slide10

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
slide11

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
slide12
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
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.
slide14

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
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