Unlike CAD for mammography, computer-aided detection used on chest scans are still being fine-tuned so as to provide radiologists and other medical professionals with a powerful, accurate tool in the fight to detect lung cancers at the earliest stage possible.

"Each anatomy has its unique challenges, and while mammography looks at a homogeneous, and sometimes dense anatomy, the chest has very dense bone and high contrast soft tissue anatomical structures that result in different, true-positive identification issues for the technology," said Sam Finkelstein, president of Riverain Medical. "In the chest, there are anatomical structures that may mimic the look of a nodule, so we have to develop advanced imaging and algorithmic tools that can discriminate between the truly suspicious nodules—that is a unique challenge."

The result of these efforts at Riverain is the company's OnGuard™ advanced CAD technology. Designed specifically for use with routine chest x-rays, the system will be part of a collaboration with the Cleveland Clinic to determine how chest x-ray CAD can improve practical early detection of lung cancer. In previous clinical trials, Riverain’s chest x-ray CAD technology helped radiologists identify16% more 9 to 15 mm solitary pulmonary nodules that were early-stage (1A) lung cancer than the radiologist would have otherwise detected without CAD. OnGuard is the only chest x-ray CAD product on the market to receive FDA premarket approval .

"Developing early detection methods is a key to improving treatment of lung cancer," said Micheal Phillips, MD, section head of imaging sciences in Cleveland Clinic's Department of Diagnostic Radiology. "As it stands now, treatment options are limited because identifying malignant lung tumors in their early stage is so difficult."

Funded through a grant from the state of Ohio, the 5-year study will evaluate the performance of the CAD system and its readers. Recruiting for the desired 9,000 test subjects will begin in early 2008.

“We believe that OnGuard can significantly improve clinicians’ ability to identify lung cancers early and have a positive impact on the rate of patient survival which amazingly hasn’t improved in over 40 years," said Finkelstein. "Riverain has been diligent in its effort to meet the rigorous standards set for its chest CAD product. We have PMA approval from the FDA, which is a higher level of standard that must be met than is required for 501(k) approval. Our efforts are dedicated to establishing the technology and its value in actual practice, and to become a new standard of care."

Currently, investigators are conducting retrospective studies to evaluate the performance of the CAD system and the readers using it. Expected to wrap up by year-end, this multiple-reader, multiple-cases research has enlisted six expert chest radiologists, six general radiologists, and six pulmonologists to assess and confirm the benefits of using chest x-ray CAD.

Each physician will be tasked with reading 200 cases of suspected lung cancer patients, of whom about 100 had cancer and 100 did not. All cases were CT confirmed, and all cancers were confirmed through either a biopsy or surgery.

Teaming with a highly respected clinical entity is key to the success of gaining acceptance of a new process for early lung cancer detection and possible screening, according to Finkelstein.

"Collaboration between industry and academia, through hospitals, is very important because centers like the Cleveland Clinic have the wherewithal to successfully merge and evaluate commercial technology with the clinical application," he said. "They can embrace and leverage the skills within their organizations to take technology and apply it to problems that haven't been solved yet, such as finding a way to achieve early detection of lung cancer. They also have the unique ability to provide metrics that reflect the true value of the technology."

He added that this is of particular importance in today's health care environment, which is increasingly focused on preventive care and pay-for-performance standards.

"Clinical organizations can take commercially available technology and make it even better—and that is when the existing technology advances so it eventually becomes a standard of care," Finkelstein said.

The 5-year study is the first in the Early Lung Disease Detection Alliance (ELDDA), an ongoing research and commercialization program that will develop, test, and bring to market new image-analysis systems for the early detection of lung cancer and other lung diseases.