Description and implementation of a quality control program in an imaging-based clinical trial.

RATIONALE AND OBJECTIVES The American College of Radiology Imaging Network is participating in the National Lung Screening Trial, a large, multicenter, randomized controlled trial, comparing multidetector helical computed tomography (MDCT) versus chest radiography (CXR) in screening for lung cancer. Because the threshold for detection of disease is an inherent function of image quality, and consistent image quality is necessary to track changes in suspicious findings, our purpose was to develop an image quality control (QC) program across all clinical sites for both modalities. MATERIALS AND METHODS The primary goals of the QC program include standardization of imaging protocols, certification of imaging equipment, and ongoing, periodic evaluation of the equipment calibration and image quality. Minimum standards for equipment and standardized cross-platform acquisition protocols are achieved via radiologist and physicist attestation forms and web-distributed technique charts, respectively. Imaging equipment performance standards are implemented through an initial machine certification process that includes equipment calibration. Ongoing assessment of equipment performance and calibration, as well as adherence to established imaging protocols. is accomplished via periodic submission of calibration records and phantom images. Participant-specific image acquisition parameters are entered into a web-based centralized database and variations from established protocols are automatically flagged for review. Participant radiation dose can be estimated from the image acquisition parameters applied to the imaging equipment calibration measurements. A radiologist visual review committee also evaluates participant images for diagnostic quality. Data are collected from 23 independent centers, representing 14 models of MDCT scanners from four manufacturers, and CXR systems that include film-screen, computed radiography, and direct digital radiography systems. RESULTS Widespread imaging protocol variation in extant clinical practice-as well as variability in equipment technology, image acquisition parameters, manufacturer terminology, and user interface-have required careful standardization as a prerequisite to trial participation and ongoing image QC. Acceptable ranges for image acquisition parameters have been refined to accommodate continuously evolving equipment platforms and the scope of participant size and body habitus. CONCLUSION Standardization of imaging protocols is a critical component of image-based clinical trials, predicated on ongoing dialogue between sites and a centralized review committee.