Abstract
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Objectives: As part of the role of IROC as an imaging quality assurance and data-banking cooperative, we have collected and performed quality-assurance on several multi-center NCI National Clinical Trial Network sponsored clinical PET imaging trials. In particular, we examine the compliancy trends of 18F-FDG uptake times in PET/CT studies accrued over the lifetime of one multi-center NCTN clinical trial utilizing strict PET acquisition guidelines, to demonstrate the effect of quality-control feedback to sites over the course of data accrual and to compare evaluating data from a strict compliant vs non-compliant approach vs a compliant vs acceptable vs non-compliant approach using heat mapping.
Methods: Using a rule-based heat-mapping quality assurance approach, our group has identified several quality parameters relating to PET/CT imaging and can assign levels of compliancy as compliant (within protocol parameters), acceptable (deviating but within acceptable tolerances) or non-compliant (significantly outside of accepted parameter values). In particular, the rates of compliancy of one parameter was chosen for observation in 458 PET/CT studies over the course of 4 years of the lifetime of a multi-center clinical trial: the FDG uptake time from the injection of 18F-FDG to the time of the PET scan acquisition. The protocol guidelines for PET/CT for this trial defines a compliant uptake time of 60 minutes with a +/- 10- minute variance. Outside of the protocol variance, a slight deviation of +5 minutes was found to result in still-evaluable data. Taking this into account, the rates of compliancy to strict non-compliancy and the rates of compliancy to acceptable (studies still found to be evaluable) to non-compliancy were compared.
Results: Using the “compliant vs non-compliant” metric, it was found that over the course of a 4-year period, the compliancy rate of uptake time of the had increased from 79 percent at year 1 to 99 percent at year 4 for 458 studies observed. When including studies whose uptake time was deviating from the protocol, though still considered acceptable for evaluability purposes, the rate had increased further, from 89 percent at year 1 to 100 percent at year 4. Conclusion: The implementation of a standard quality assurance with feedback can result in increased rates of compliance over the course of a clinical trial with an imaging component. When using a heat map approach to further evaluate non-conformant uptake time parameters as acceptable, the potential rate of the number of scans evaluable for the study increases. Research Support: ODSA TECH 13-060 (IPP), NCI 5U24CA180803 (IROC)