FDA approves first 3-D mammography imaging system

The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.

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Mammography availability linked to breast cancer mortality rate

More women die of breast cancer in areas where mammography centers are few and far between, according to research by a Medical College of Georgia radiology resident.

Breast cancer mortality rates ranged from 34.1 per 100,000 women in counties with no mammography facilities to 27.5 in those with at least one, said Dr. Kandace Klein, a fourth-year radiology resident.

Drs. Klein and James Rawson, Warren professor and chair of the Department of Diagnostic, Therapeutic and Interventional Radiology, presented their findings at the recent annual conference of the Radiology Society of North America. Dr. Klein also received the society’s Trainee Research Prize for the project.

Researchers used mapping and statistical software to determine the relationship between the number of sites in a specific geographical area and the number of breast cancer deaths. While this phase of the research did not account for variables such as race, education or socioeconomic status, a noticeable pattern emerged.

“The number of sites within a county is related to the population,” Dr. Klein said. “Increasing access to a facility correlates with a decrease in mortality.”

Researchers could not account for mobile mammography units and any transfer cases, such as when a patient went to another county to receive mammography services. The next phase of the project will analyze other factors that could affect breast cancer mortality rates, she said.

Dr. Klein, a graduate of the Texas College of Osteopathic Medicine, will complete her residency this spring and begin an MCG fellowship in body imaging.

By Jennifer Hilliard
MCG

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American College of Surgeons Voices Strong Support for American Cancer Society Screening Mammography Guidelines

/PRNewswire/ -- The American College of Surgeons (ACoS) today released comments strongly supporting current American Cancer Society (ACS) screening mammography guidelines that recommend women get a mammogram every year, starting at age 40. The College is supporting the ACS guidelines despite the recommendations from the U.S. Preventive Services Task Force stating the women should have regular mammograms once every two years beginning at the age of 50. The College believes the ACS guidelines have resulted in an effective approach toward dealing with the possibility of breast cancer and that women should continue to follow them in consultation with their physicians.

The federal panel's position that regular mammography screening in women under the age of 50 may do more harm than good was dismissed by David P. Winchester, MD, FACS, Medical Director of ACoS Cancer Programs, and Chair of the National Accreditation Program of Breast Centers. Dr. Winchester was particularly concerned about the panel's belief that mammography may cause an increased risk of false-positive results in younger women who have denser breast tissue, observing that "the term unnecessary biopsy is misleading. In most cases," he said, "biopsy -- done by either surgeons or radiologists -- is the reliable way to rule out cancer at any age."

The College notes that the American Cancer Society has long recognized mammography "as the gold standard for early detection of breast cancer,"* and ACoS encourages women to take an active role in partnering with their physicians to determine at what age, and what interval, they should undergo screening mammography. The College agrees with the ACS that factors such as a woman's family history of the disease and her overall medical condition are some of the issues that should be addressed, particularly for women who are known to be at an increased risk for developing the disease.

"Many surgeons in this country have the tremendous responsibility and privilege of caring for breast cancer patients each day. While recognizing that mammography is not perfect and supporting continuing research for improved methods, the surgical community believes that the American Cancer Society's screening mammography guidelines offer an optimal approach to detecting breast cancer early, when it can be most successfully treated," Lamar S. McGinnis, Jr., MD, FACS, President of the American College of Surgeons and former president of the American Cancer Society, said. "Mammography is a good and safe tool, which we will continue to improve. In the meantime," he added, "let's save lives as best we can. The lives of women, mothers, and grandmothers are invaluable. Our progress has been significant, and it will continue. Let us not confuse our patients and the public with mixed messages."

About the American College of SurgeonsThe American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and to improve the care of the surgical patient. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 77,000 members and is the largest organization of surgeons in the world. For more information, visit www.facs.org.

In the field of cancer care, the American College of Surgeons Commission on Cancer (CoC) is a pioneer in measuring performance. All hospitals and freestanding cancer treatment facilities approved by the CoC report clinical data through the National Cancer Data Base and receive evidence-based benchmark comparison reports based on accepted standards of care for breast and colorectal cancers. These measures are endorsed by the National Quality Forum. In addition, the College administers the National Accreditation Program for Breast Centers (NAPBC), a consortium of national, professional organizations dedicated to the improvement of the quality of care and the monitoring of outcomes for patients with diseases of the breast.

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