FDA Approves 3-D Mammogram Screening

The Food and Drug Administration has just granted its approval for Selenia Dimensions System, a new three dimensional mammogram system developed by Holigic, Inc. This new system will be used for breast cancer screening. By using the three dimensional image it should allow for a much clearer picture and provide elimination of overlapping tissue that is observed in conventional screening.

Mammograms produce two dimensional images but this new screening will allow for two and three dimensional screening. This now will enable radiologists and practitioners to be able to do a comparison of a patients past two dimensional mammogram side by side with the more complete information from the three dimensional image.

Robert Cascella, Hologic, Inc., chief executive states that they believe this new imaging will decrease the unnecessary repeated screenings and hopefully will detect cancer earlier and be able to save more lives.

This medical device had already been approved for use in Europe, Asia, Latin America, Mexico and Canada. Prior to receiving today's approval these systems were being installed in the United States and being used exclusively for two dimensional imaging. With today's final FDA approval, Hologic can go ahead and upgrade the systems to perform three dimensional functions.

In a statement released today by the FDA, it was stated that the traditional mammograms are still the best way to determine breast cancer. However, do to the fact the technology is limited it does at times require women to be screened again. Examining an additional three dimensional image aides practitioners to locate more cancers than with two dimensional images solely. Exactly, ten percent of women require additional testing after the first screening for abnormalities that later on had been determined to be non-cancerous.

The disadvantage to this device is in combination of both two and three dimensional images exactly doubles the amount of radiation dose the patient receives. On the other hand, the accuracy is improved for radiologists to discover cancer. This lessens the amount of women who have to have another screening done.

The National Cancer Institute recommends mammograms for women aged forty and older every one or two years. Estimates indicate that 40 million mammograms are done each year in the United States.

Early Results

Dr. Stephen Poplack, radiologist at Dartmouth Medical School and on Hologic scientific advisory board states this new technology appears to be impressive.

This new system uses several low dose x-rays to create a three dimensional view of the breast. This aides by eliminating many of the typical problems of imaging such as overlapping tissue and shadows which most of the time makes diagnoses very hard.

In order to determine its effectiveness Dr. Poplack had compared diagnostic mammograms of 98 women with matching ones of the new system. In 88% of the cases the new system had give views which were comparable to or far greater than conventional mammograms. For the image to be deemed superior Dr. Poplack and his assistant Dr. Helene Nagy, had to be able to see the abnormality better and collect more information to make a diagnosis.

Currently this new technology appears to be strong. Dr. Poplack believes it is also effective as a screening tool. In an example cited if the new device was used instead of the standard mammogram on the 98 women in the study almost half of the women would not have had to have repeat screening.

Dr. Kristine Byrne, chief of breast imaging for New York's Lennox Hill Hospital states that around ten percent of women have to have another screening because the first mammogram was not clear enough, this is where the three dimensional imaging could help resolve the problem. Dr. Byrne also believes it will help with patients who have dense breast tissue and believes this new three dimensional screening will eventually end up being standard practice.

Studies have shown the three dimensional imaging is just as good as the two dimensional in the detection of cancerous growths and it does aide in lessening the rate of false positives, those abnormalities that turn out to be non-cancerous. Eventually, it could decrease the number of needless biopsies.

The FDA is requiring that the three dimensional images be taken in conjunction with the two dimensional imaging.

Erica Jefferson, spokesperson for the FDA states both images are required due to the fact the way Hologic studies demonstrated the effectiveness of the technology. No comparison was presented between two dimensional and three dimensional.

As the technology improves and radiologist become familiar with its three dimensional imaging technology, the FDA then may approve a device that is just intended for three dimensional imaging.
Sources:

Health News

Dart Med

LA Times