Testing of Computer Aided Detection Software for Riverain Medical Group
In 2000, data was presented to the FDA to demonstrate that a new system for computer
analysis could assist radiologists in the detection of small lung cancers on chest
radiographs. Radiologists using the system showed a statistically significant improvement in
lung cancer detection rate when they used the system, compared to their interpretation of
chest radiographs when they did not use the computer system. This study, along with other
supporting data, resulted in the FDA giving Pre-Market Approval for the system.
The system has undergone several improvements in software and hardware, and it is now
intended to test two different software systems to determine whether radiologists using the
systems can improve their detection of lung cancer on chest radiographs.
One of these systems processes the chest radiograph to decrease the emphasis given to the
shadow of the ribs and thereby enhances the ability of radiologists to detect disease in the
lungs. The second system performs a series of evaluations on chest radiographs and, based on
a complex system of analysis, points to locations on the chest radiograph that contain
solitary pulmonary nodules having the characteristics of primary lung cancer or solitary
metastases of cancer to the lungs.
This will be a test of radiologists to determine the degree of improvement, if any, that
results when they interpret chest radiographs that may or may not have cancer, first
interpreted without the computer and, second, with the images output by the software.
Improvement in cancer detection as measured by ROC methodology
Three days of experiment over 3-5 months
Matthew T. Freedman, MD, MBA
United States: Institutional Review Board
Riverain SV 2.0.1 and OG5.0
|ISIS Imaging Science Research Center, Georgetown University||Washington, District of Columbia 20057|