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The U.S. Food and Drug Administration recently approved the use of new computer-aided detection (CAD) MammoReader software made by ICAD,
Inc., which helps doctors detect breast abnormalities on mammogram
films. In January 2003, ISSI, Inc. received FDA approval for their CAD mammography system.
CAD works by digitizing a mammogram film and then highlighting areas that may be represent
suspicious breast abnormalities. Radiologists can decide whether the computer-highlighted
areas require additional evaluation, based on the patient’s situation. Similar
software made by R2 Technology, Inc. is also FDA-approved and on the market. These recent
government approvals suggest that radiologists may increasingly rely on computer-assisted
technology to help diagnose breast cancer.
Computer-aided detection (CAD) technology is a recent advance in the field of breast
imaging. The CAD technology essentially works as a second pair of eyes, reviewing a
patient's mammogram film after the radiologist has already made an initial interpretation.
If the computer software detects any breast abnormalities or "regions of
interest" on the mammogram film, it marks them. The radiologist can then go back and
review the mammogram film again to determine whether the marked areas are suspicious and
require further examination (with additional imaging tests or biopsy).
With the CAD technology, the radiologist still makes the final interpretation of the
mammogram.
Using sophisticated pattern recognition computer software, the CAD technology is
designed to detect the following abnormalities on mammogram films:
- Patterns of bright spots that suggest microcalcifications
(tiny calcium deposits that may indicate cancer)
- Dense regions with or without radiating lines that suggest breast masses or distortions
A study presented at the 2000 Radiological Society of North America (RSNA) meeting
found that using R2 Technology’s CAD software increased the detection of breast
cancer by approximately 20%. Among the 12,860 women in the study, 49 cancers were
detected:
- 32 cancers were detected by both CAD technology and by the radiologist, who interpreted
the women’s regular mammogram films
- nine cancers were detected by the radiologist alone
- eight cancers were detected by the CAD technology alone (the radiologist then reviewed
the mammogram films again to find the suspicious areas)
Referring to his company’s MammoReader CAD system, Michael Palazzola, President of
Instrumentarium Imaging Inc., said in a news release that, "This is an important
breakthrough in the fight against breast cancer. He continued, "Its pricing, starting
at $99,500, allows all breast care centers the opportunity to offer this product, thus
benefiting a larger population who otherwise would not have access to this
technology."
In a study reported by ISSI, researchers evaluated 327 cancer cases and found that 23%
of the women could have been diagnosed with breast cancer at an average of 14 months
earlier than they had been if their mammograms had been read with the assistance of the
MammoReader CAD system. Similarly, ICAD boosts that their new CAD MammoReader software has
a 90.5% sensitivity for detecting breast masses.
Though it appears as though the use of computer-aided detection of breast abnormalities
on mammogram films will increase, some radiologists worry about potential limitations of
the technology. For example, the CAD technology can mark "normal" areas on
mammograms as abnormalities, which may lead to the ordering of additional unnecessary and
costly breast imaging and/or biopsies.
Nevertheless, computer-aided detection has potential to help detect breast cancer in
earlier stages, when the chances of surviving the disease are the greatest. Standard film
mammography, the currently the gold standard of breast cancer detection, detects
approximately 85% of all breast cancers. Computer-aided technologies have the potential to
increase that detection rate.
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