A study published in the August issue of Radiology shows that breast cancer detection was improved by 7.4% through use of R2 Technology, Inc.'s ImageChecker(R) computer aided detection (CAD) system, the company announced today.
The findings are significant because this is the first prospective published study of its kind to be conducted in an academic medical setting, which is typically staffed by the most highly trained radiologists.
The study of 8682 women was led by Dr. Robyn Birdwell and her former colleagues at Stanford University Hospital, Palo Alto, California.
"Breast cancer can be very challenging to detect and subtle clues can be missed by even the most experienced radiologist. This challenge is made even more difficult by the stress radiologists face to increase their efficiency and limit the number of women being recalled unnecessarily for further analysis," said Dr. Birdwell. "Performed in our university hospital setting, our results show that, even among the most highly-trained radiologists, R2's CAD system helps detect cancers that would have otherwise been overlooked."
The study was conducted over an 18-month period on women with a median age of 54 years during routine mammography screening. Each mammogram was initially interpreted by a radiologist, followed immediately by reevaluation of the mammogram with R2's CAD system. Each recall was categorized as: both the radiologist and CAD agreed on the finding; the radiologist alone perceived the finding; or, R2's CAD prompted the radiologist to detect and act on the finding.
The recalled patients were then tracked to determine the effect of CAD on the cancer detection and recall rates, among other findings.
The study found that, by using R2's CAD system, the radiologists increased their cancer detection rate by 7.4%. The increase in the recall rate for patients was similar to the increase in the cancer detection rate.
"This new study further validates R2's ImageChecker CAD system's effectiveness in improving cancer detection rates in screening mammography," said Dr. Ronald A. Castellino, R2 Technology's chief medical officer. "This study shows that, even in an academic setting, our technology can give radiologists added confidence that they are detecting more breast cancers earlier."
CAD technology is used by increasing numbers of radiologists as "a second pair of eyes" when reading mammograms. Five independent prospective clinical studies* have shown that the use of R2's CAD resulted in 6.6% to 19.5% more cancers detected. Clinical studies* comparing architectural distortions, cases graded by difficulty, and small invasive breast cancers all demonstrate the performance advantage of R2's market-leading CAD algorithm.
R2's ImageChecker system was the first CAD system approved by the U.S. Food and Drug Administration (FDA) for use with film-screen mammography in 1998 and for digital mammography in 2001. Since 1998, the company has received multiple supplemental approvals for technological and clinical advances and owns or has exclusive worldwide rights in more than 120 issued and pending patents.
To date, more than 1600 ImageChecker CAD systems have been shipped worldwide and this year approximately nine million women will have their mammograms interpreted with the aid of R2's leading CAD technology.