Riverain Medical - Men`s Health Network

Riverain Medical
OnGuard™ Chest X-ray CAD
Practical early detection
David Fryd, Ph.D.
Vice President of Clinical Affairs
dfryd@riverainmedical.com
Kevin McBride
Vice President of Sales
kmcbride@riverainmedical.com
Riverain Medical
3020 South Tech Blvd.
Miamisburg, OH 45342
(800) 990-3387
Agenda
Riverain Medical Background
Lung cancer incidence, survival and detection
statistics
What is computer-aided detection?
Detecting lung cancer with chest x-rays and CAD
Riverain Medical
• Riverain is privately held with headquarters in Dayton, Ohio.
• Riverain’s mission is to save lives by improving the detection and diagnosis of
diseases and other clinical conditions.
Clinical Collaborators
• U.S.
•Cleveland Clinic
•Georgetown University Medical Center
•University of Chicago
•University Hospitals (Case Western Reserve)
•University of Maryland
•University of Minnesota
• Europe:
•Southheart Hospital, Nordhausen, Germany
•Inselspital, Bern, Switzerland
•University of Vienna
•Academic Medical Center, University of Amsterdam
Core Technical Competencies
• Computer-Aided Detection technology
• Quantitative image analysis
• Pattern recognition and machine learning
• Quantitative image analysis
• Image understanding
• Region detection and segmentation
• Region characterization through automatic measurement processes
• Pattern recognition and machine learning
• Data understanding
• Automated decision making
Lung cancer is the leading cancer killer
Each year, lung cancer takes
more American lives than any
other single form of cancer
250000
200000
In 2008, an estimated 215,020
Americans will be diagnosed with
lung cancer, 160,000 will die of it.
Lung cancer accounts for
approximately 15% of all cancer
diagnoses but 30% of all cancer
deaths.
150000
100000
50000
0
Lung
Source: American Cancer Society
Cancer Facts & Figures 2008
Colon
New Cases
Breast
Prostate
Deaths
Lung cancer & men
Lung cancer is the leading cause of cancer death among
men
Approximately 114,000 men will be diagnosed with lung
cancer this year - 90,000 will die from it
More men will lose their battle with lung cancer than colon
and prostate cancers combined1
1American
Cancer Society, Facts and Figures 2008
Early detection saves lives
The five-year survival rate increases from 16% to 49% when lung cancer is detected
in its earliest stages†.
Tragically, only 16% of lung cancers, are detected in the early stage when the
disease is still in a localized stage and most treatable†.
When lung cancer is found in Stage I and II it can be surgically removed.
Chemotherapy after successful lung resection has been shown to increase survival
rates from 54% to 69% in a randomized clinical trial*.
The Prostate, Lung, Colorectal, and Ovarian cancer screening trial demonstrated
that lung cancer can be found from chest X-rays of individuals who are current or
former smokers and those who never smoked±. In fact, more lung cancers are
detected from chest X-rays than from CT scans∞.
Sources:
† American Cancer Society, Cancer Facts and Figures 2008
* Winton, T., Livingston, R., Johnson, D. et al (2005). Vinorelbine Plus Cisplatin vs Observation in Resected Non-Small-Cell Lung Cancer. New England Journal of Medicine. 352, 2589-2597.
± Oken MM, Marcus PM, Ping HU et al (2005). Baseline Chest Radiograph for Lung Cancer Detection in the Randomized Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Journal of the National Cancer Institute.
97:1832–9.
∞ Altorki N, Kent M, and Pasmantier M. Detection of early-stage lung cancer: computed tomographic scan or chestradiograph? J Thorac Cardiovasc Surg 2001;121:1053-7.
Lung cancer is difficult to detect
Lung cancer is often not detected until it is in advanced stages
Lung cancer can be difficult to detect due to the complex structures of the chest
Several studies have revealed that radiologists miss 22-71% of lung cancers smaller
than 30mm.+*
Sources:
Quekel LGBA,. Kessels AGH, Reginald Goei R, et al. Miss Rate of Lung Cancer on the Chest Radiograph in Clinical Practice Chest 1999;115;720-724
* Austin JHM, Romney BM, and Goldsmith LS. Missed Bronchogenic Carcinoma: Radiographic Findings in 27 Patients with a Potentially Resectable Lesion Evident in
Retrospect. Radiology 1992; 182:115-122.
†
Chest X-rays facts
When a physician suspects a patient may have
lung cancer, typically a chest X-ray is ordered.
Currently, chest X-rays are the most cost-effective,
widely used, non-invasive and readily available method
for detecting chest and lung diseases‡.
Chest x-rays are low radiation procedures.
80 million chest X-rays are taken in the U.S. each
year‡.
40% of hospitals’ radiology department procedures are
chest X-rays‡.
American College of Chest Physicians’ guidelines
recommend a chest X-ray for patients with cough and
risk factors for lung cancer†.
Sources:
‡National Institutes of Standards and Technology, an agency of the U.S. Commerce Department’s Technology Administration
† Kvale, P.A. (2007). Chronic cough due to lung tumors: ACCP evidence-based clinical practice guidelines. Chest. 129 January Supplement, 147S-153S.
CAD is a widely-used technology
OnGuard™ Chest X-ray CAD process
The patient receives a chest Xray as part of an unrelated
procedure or due to a concern
over a symptom associated
with lung cancer
The radiologist
reviews the chest Xray without OnGuard.
The radiologist then views the
OnGuard image which circles
a very subtle nodule that may
not have been detected without
OnGuard.
OnGuard™ Chest X-ray CAD results
OnGuard™ Chest X-ray CAD
OnGuard Chest X-ray CAD detects
solitary pulmonary nodules
9-30 mm in size*.
9 mm
30 mm
Lung cancer is most treatable when detected in stage I (less
than 30 mm)†.
The five-year survival rate for lung cancer increases from 16% to
49% when it is detected in stage I†.
Sources:
†American
Cancer Society, Cancer Facts & Figures 2008
*Riverain Medical 2001 Clinical Trial for Food and Drug Administration Pre-Market Approval
OnGuard™ Chest X-ray CAD benefits
Clinical studies have shown that chest X-ray CAD helps radiologists identify 16%
more early stage (9mm-14mm) lung cancer than a radiologist would detect otherwise
without CAD*.
Fifteen community-based board-certified radiologists read chest x-ray images
without and with chest X-ray CAD. Ten of the fifteen radiologists significantly
improved their detection rate of early stage lung cancer using chest X-ray CAD*.
Chest X-ray CAD marked more than 33% of lung cancer cases that were missed by
radiologists in actual practice†,α.
Source:
*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 Cancers on Chest Radiographs. Radiology. 246, 273-280.
α. Chen JJ, White CS (2008) Use of CAD to evaluate for Lung Cancer on Chest Radiography. J Thoracic Imaging; 23:93–96.
OnGuard™ Chest X-ray CAD
Riverain’s chest X-ray CAD was approved by the Food & Drug Administration
(FDA) in July 2001 for early detection of lung cancer*.
Riverain’s chest X-ray CAD was approved for an AMA Category III CPT code
effective July 1, 2005 for Chest CAD Radiography.
Patients do not need to take any additional action after having a chest X-ray
taken to benefit from the utilization of CAD – the technology is applied to the Xray image and the analysis is sent directly to the radiologist for consideration.
Patients are not exposed to any additional radiation because CAD analyzes the
existing chest X-ray images.
Source:
*Food and Drug Administration Pre-Market Approval 2001
OnGuard™ Chest X-ray CAD testimonials
“In the first year that we’ve used the system, we found four lung cancers. Three of
them I picked up without using the CAD unit. The fourth one the CAD unit just
helped me take a second look and say, ‘Hey, yeah there really is something
there.’”
»
Dr. Mark Alder, Radiologist, Ogden Clinic - Ogden, Utah
“We had a young man who was coming in for a surgical procedure on his
shoulder, had a pre-operative chest X-ray. We had really no reason to believe that
he would have any disease in his chest – other than the fact that he did have some
smoking history. The [Riverain Medical’s Chest X-ray] CAD did discover a small
nodule in the chest. A follow-up CT did show that it was a true lung cancer. That
lung cancer was successfully removed, and the patient is actually doing very
well.”
»
Mr. Jim Williamson, Director of Radiology, Garden City Hospital - Garden City, MI