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SynaVu™ Digital X-ray Reading System
Radiographic assessment of joint destruction in clinical trials of rheumatoid arthritis has become a highly sophisticated process. It begins with careful radiography of the hands and feet using standardized techniques and positioning templates designed to ensure reproducible projection of the joints on serially acquired images from multiple centers involved in a study. The analog images from these multi-center examinations are then centrally digitized to allow more secure and economical archival, rapid recovery and distribution to multiple readers, and electronic submission to regulatory agencies. Digitally acquired images are loaded into the same data system.
These electronic images are analyzed by specially trained and highly experienced radiologists using reading workstations (SynaVu™) equipped with high-resolution monitors.
The SynaVu™ system edge-enhances the digital images using unsharp masking to maximize the delineation of cortical and trabecular bone. It then strips the images of all identifying information to ensure reader blinding, and presents the images to the reader side-by-side as serial sets for each subject in order to maximize the reader's ability to detect the smallest changes over time. Examination order is usually randomized to maintain chronological blinding. The SynaVu™ system also provides the reader with a number of tools to further optimize image quality and aid analysis. This includes image window and level adjustment, zoom and panning functions, and validated electronic score sheets with reader sign-off and automatic databasing of the results.
Coupling specially trained expert readers with this enabling and enhancing technology makes centralized reading for clinical trials an integrated process and maximizes precision, speed and regulatory compliance. Synarc's radiologists have evaluated over 30,000 hand and foot radiographs using the validated SynaVu™ reading system. |
