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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


Anthony m levering assistant director core lab

Lead

Tech

Supporting

Tech

Communication is Key

Institution

Principal Investigator

ACRIN

Treatment

Arm

Imaging

Arm

?

?

?

Radiologist

RA


Anthony m levering assistant director core lab


Anthony m levering assistant director core lab

  • 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


Anthony m levering assistant director core lab


Anthony m levering assistant director core lab

  • Increase involvement of site technologists trial-specific test case

    • 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


Anthony m levering assistant director core lab

  • 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.


Anthony m levering assistant director core lab

Assuring Quality qualification.

  • 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


Anthony m levering assistant director core lab

DICOM Meta-data qualification.

  • 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


Anthony m levering assistant director core lab

  • Technical parameters not followed qualification.

  • 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 qualification.

  • 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.


Anthony m levering assistant director core lab

Suggested Solutions qualification.

  • 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


Anthony m levering assistant director core lab

Compliance - Like magic! qualification.