Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation.

Area of Science:

• Medical Imaging
• Radiology
• Biomedical Engineering

Background:

• Dynamic Contrast Enhanced-Computed Tomography (DCE-CT) is increasingly used as a companion biomarker in clinical trials.
• Ensuring data quality and comparability across institutions and scanners is crucial for trial validity.
• Standardized quality assurance (QA) and control methods are needed for DCE-CT.

Purpose of the Study:

• To develop and evaluate a DCE-CT QA protocol using a dynamic flow imaging phantom.
• To address the challenge of data variability in multicenter clinical trials using DCE-CT.
• To ensure minimal deviation in results between different scanners and institutional protocols.

Main Methods:

• A validated dynamic flow phantom was used to create a DCE-CT QA protocol.
• The protocol incorporated quantitative metrics like injected and total mass error, and goodness of fit.
• Region of Interest (ROI) sensitivity analysis was performed to assess variability and optimal ROI sizes.

Main Results:

• The phantom demonstrated high robustness with <2.2% intraday variability and R2 > 0.99.
• The QA protocol detected significant deviations under suboptimal scanning parameters (low mAs/kVp).
• The protocol successfully validated DCE-CT imaging across three institutions in <90 minutes, enhancing data confidence.

Conclusions:

• A DCE-CT QA protocol was developed, effectively separating intrascanner variability from other factors.
• The protocol, combined with a dynamic flow phantom, is a valuable resource for clinical trial institutions.
• It ensures scanner performance and adherence to imaging protocols and accuracy requirements for dynamic scans.