Chicago, November 26, 2007 - Cleveland Clinic and Riverain Medical today announced the establishment of the first study in an ongoing program to determine whether chest X-ray CAD (computer-aided detection) can improve practical early detection of lung cancer. The program is designed to determine whether chest X-ray CAD can help identify hard to detect lung cancers at an early stage when they are most treatable, leading to improved patient survival rates.
The announcement of the clinical program was made at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America being held November 25-30, 2007, in Chicago, IL.
"Developing early detection methods is a key to improving trea™ent of lung cancer," said Micheal Phillips, M.D., Section Head of Imaging Sciences in Cleveland Clinic's Depar™ent of Diagnostic Radiology. "As it stands now, trea™ent options are limited because identifying malignant lung tumors in their early stage is so difficult."
The evaluation of X-Ray CAD is being funded by a grant from the State of Ohio. Moulay Meziane, M.D, is the principal investigator for the five-year study that will involve 9,000 test subjects. Investigators are currently conducting retrospective studies to evaluate the performance of the CAD system and the readers using it. The participants for the clinical trial will be enrolled in early 2008.
The Significance of Chest X-ray CAD (Computer Aided Detection)
Lung cancer kills more people in the United States annually than breast, prostate and colon cancers combined.* Eighty million chest X-rays are taken each year for a variety of reasons including persistent cough, routine physical exam, pre-operative preparation and many others. ♦ Chest X-rays are then viewed and analyzed by radiologists who provide an evaluation based on a visual assessment of the chest radiograph evaluation of the results. However, without chest X-ray CAD, many lung cancers may not be found or are overlooked when lung cancer is most treatable.
With chest X-ray CAD, the software "looks at" the X-ray, identifies regions of interest (actionable/suspicious pulmonary nodules), and circles them for further analysis. The radiologist is then able to review these suspicious areas more closely and determine whether additional follow-up, such as a CT scan, is needed for further evaluation/diagnosis. Chest X-ray CAD does not expose the patient to any additional radiation exposure or require any additional action by - or involvement of - the patient; CAD is applied by the radiologist after the chest X-ray is taken. CT scans or magnetic resonance imaging (MRI) are effective diagnostic follow-up methods for chest X-rays that have suspicious findings.
In previous clinical trials, Riverain's chest X-ray CAD technology helped radiologists identify16 percent more 9-15 mm solitary pulmonary nodules that were early stage (1A) lung cancer than the radiologist would have otherwise detected without CAD. OnGuard™ is the only FDA-PMA approved chest X-ray CAD product on the market.‡‡
"Unfortunately, most lung cancers are diagnosed too late for trea™ent to potentially save lives," said Sam Finkelstein, President of Riverain Medical. "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."
About the Clinical Program
The Cleveland Clinic Foundation and Riverain Medical, along with Wright State University and University Hospitals Health System, have joined together to form the Early Lung Disease Detection Alliance (ELDDA), a multidisciplinary research and commercialization program that will develop, test (through clinical trials), and bring to market new image-analysis systems that permit the early detection of lung cancer and other lung diseases. This computer-aided detection (CAD) system will be applied to the most widely available and used imaging exam, the chest x-ray. The goal is to not only advance the early detection of lung cancer and other diseases but also accelerate the commercialization of computer-aided detection, image interpretation, and multidisciplinary applications of computer science and medical diagnostics.
The current retrospective study is a multiple-reader multiple-cases study involving six expert chest radiologists, six general radiologists, and six pulmonologists to assess the usefulness of CAD. Each reader will read 200 cases of suspected lung cancer of which about 100 had cancer and 100 did not. All cases were CT confirmed. All cancers are biopsy or surgically confirmed.
The study is expected to be completed by the end of the year. Investigators from Cleveland Clinic include Dr. Phillips, Moulay Meziane, M.D., Section Head of Chest Imaging, Peter Mazzone, M.D., Staff Pulmonary Medicine and Nancy Obuchowski, Ph.D., Vice Chair, Depar™ent of Quantitative Health Services.
Previous Studies Establish Value of OnGuard™ Chest X-Ray CAD
- Fifteen community-based board-certified radiologists read chest X-ray images without and with chest X-ray CAD. Forty-two percent and 22 percent of nodules sized 9-14 mm and 20-27 mm, respectively, were missed. Ten of the 15 radiologists improved their detection rate using chest X-ray CAD; they benefited in detecting Stage I cancers of all sizes between 9 and 30 mm (10 percent improvement) and benefited most from those between 9 to 15 mm (16 percent improvement). This study was the basis for the Food and Drug Administration's approval of Riverain's chest X-ray CAD technology. ‡‡
- Researchers at the University of Chicago used Riverain's CAD to analyze chest X-rays from patients whose lung cancer was initially missed by radiologists; CAD identified 37 percent of the missed cancers for which radiologists would have recommended further diagnostic testing. §§
- Researchers at the University of Maryland conducted a similar study that also included patients from the VA hospital. The results indicated that chest X-ray CAD properly identified cancers in 37 percent of the patients whose cancers were missed.± In both studies of missed lung cancers, with the initial use of CAD, these patients may have had their cancers diagnosed earlier.
Facts About Lung Cancer
- Only 16 percent of lung cancer cases are detected while the disease is still in a localized stage and most treatable. The five-year survival rate increases from 16 percent to 49 percent when the disease is detected in its earliest stages.*
- The American College of Chest Physicians' (ACCP) guidelines recommend a chest X-ray for patients with cough and risk factors for lung cancer or metastatic cancer.**
- Chest X-rays have been found to be effective at detecting early-stage lung cancer while it is still treatable.††
- Chest X-ray computer-aided detection (CAD) detects 16 percent more solitary pulmonary nodules that may be early-stage lung cancer than a radiologist would detect without CAD. ‡‡
Morbidity and Mortality
- In 2007, an estimated 213,380 Americans will be diagnosed with lung cancer, accounting for approximately 15 percent of all cancer diagnoses.*
- Lung cancer accounts for approximately 29 percent of all cancer deaths, and will kill an estimated 160,390 Americans in 2007.*
- As many as 15 percent of people with lung cancer are non-smokers†
- Over the last 60 years, female deaths from lung cancer have increased 600 percent.*
- African American men are 50 percent more likely to develop lung cancer than Caucasian men. Additionally, African American men are 36 percent more likely to die from lung cancer than Caucasian men.‡
- Two-thirds of all lung cancer cases are among people aged 65 years and older.§
About Cleveland Clinic
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education. Cleveland Clinic was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Approximately 1,800 full-time salaried physicians and researchers at Cleveland Clinic and Cleveland Clinic Florida represent more than 100 medical specialties and subspecialties. In 2006, there were 3.1 million outpatient visits to Cleveland Clinic. Patients came for trea™ent from every state and from more than 80 countries. There were more than 53,000 hospital admissions to Cleveland Clinic in 2006. Cleveland Clinic's Web site address is www.clevelandclinic.org.
The Section of Thoracic Imaging has six full time chest radiologists providing subspeciality expertise and interpretation for 130,000 chest radiographs and 20,000 chest CT's annually. Twice as many chest exams are performed annually by the different regional practices of Cleveland Clinic's Imaging Institute.
About Riverain Medical
Riverain Medical, LLC is a privately-held medical software technology company headquartered in Dayton, Ohio, specializing in computer-aided detection (CAD) of diseases, such as lung cancer. The company's staff is comprised of seasoned medical advisors, regulatory and quality analysts, programmers, and managers that have spent their entire careers in healthcare. Riverain's ownership and management team have extensive experience in the medical products industry, with an emphasis on research and development and the successful commercialization of medical technologies.
Riverain has introduced the first FDA-PMA approved chest X-ray CAD product. Using conventional chest X-rays, Riverain's OnGuard™ system assists radiologists in identifying features associated with solitary pulmonary nodules that could represent early-stage lung cancer and require further investigation.
* American Cancer Society Facts & Figures 2007
♦ National Institutes of Standards and Technology, an agency of the U.S. Commerce Depar™ent's Technology Administration
‡‡ Riverain Medical 2001 Clinical Trial for Food and Drug Administration Pre-Market Approval §§Li, F., Engelmann, R., Metz, C. & et al (2007). Results Obtained by a Commercial computer-aided Detection (CAD) Program with Radiologist Missed Lung Cancer on Chest Radiographs. Radiology. In Press.
±White, C., Flukinger, T. & Jeudy, J. (2006). Use of a Computer-Aided Detection System To Detect Missed Lung Cancer on Chest Radiographs. Radiology Society of North America.
** Kvale, P.A. (2006). Chronic cough due to lung tumors: ACCP evidence-based clinical practice guidelines. Chest. 129 (1), 147S-153S January Supplement.
†† Oken, M.M., Marcus, P.M., Ping, H.U. & et al (2005). Baseline Chest Radiograph for Lung Cancer Detection in the Randomized Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Journal of National Cancer Institute. 97, 1832-1839.
† American Cancer Society Lung Cancer Key Statistics 2006
‡ American Cancer Society Cancer Facts & Figures for African Americans 2007-2008
§ Environmental Protection Agency (2005). Costs of Illness for Environmentally Related Health Effects in Older Americans.