In 2003, Nancy Cappello, PhD, then age 51, went for a mammogram as she has every year since turning 40. A healthy eater and regular exerciser, Dr. Cappello received the report she expected: normal. Two months later, a routine gynecological exam found a thickening in her breast. She went back for another mammogram, which again was normal. A targeted, diagnostic ultrasound finally picked up the 2.5-cm palpable lump in her breast-a lump that proved to be stage IIIC cancer.

Today, after a single mastectomy, the removal of 18 lymph nodes (13 of them cancerous), chemotherapy and radiation, Dr. Cappello is healthy once more-but still upset by the circumstances surrounding her diagnosis.

She was "shocked" to learn, well after the fact, that she had dense breast tissue and that breast density is a risk factor for cancer.¹"I was so outraged that I'd never heard of this before," said Dr. Cappello, a public education consultant in Woodbury, Conn. "Are there other women like me?"

In fact, more than half of women younger than 50 have dense breasts, as do a third of women past 50. Some research suggests screening such women with a combination of mammography plus ultrasound would find more breast cancer than mammography alone.²

False positives

Ultrasound as a breast cancer screening tool suffers from two main drawbacks, however: Insurers don't pay for it, and it has a significant false-positive rate, resulting in increased biopsies. "There are more false-positive screenings with ultrasound than with mammography, for all breast densities," says Stephen Feig, MD, professor of radiology at the University of California, Irvine. "So we must refine it. Can we reduce biopsies by, say half, and still find cancers? That must be investigated."

Constance Lehman, MD, PhD, uses traditional ultrasound every day in her practice-but not as a screening tool. "I use it to evaluate palpable lumps in the breast and abnormalities seen on the mammogram," says Dr. Lehman, professor and vice chair of radiology and section head of Breast Imaging at the University of Washington Medical Center, Seattle. "It is a highly accurate and very important imaging tool to evaluate women with palpable lumps in their breasts and women with abnormal mammograms."

However, a lot more research is needed before ultrasound becomes a recommended cancer screening tool for women with dense breast tissue, Dr. Lehman says-and that holds true for any of the new automated versions of whole-breast ultrasound (see sidebar). "There is a lot of divergent opinion about the efficacy of traditional screening ultrasound and even less is known about automated full-breast ultrasound," she says. "Much research doesn't support it as an effective tool."

Studies underway

Two studies-one published, one ongoing-could bring new attention to automated ultrasound as a breast cancer detector, however.

A recent peer-reviewed study showed that mammography combined with SonoCiné Inc.'s automated ultrasound system found more and smaller-sized cancers than mammography alone.³The positive predictive value of biopsies from ultrasound were higher than reported in studies involving handheld ultrasound: 38 percent vs. 8 percent.

Then there's the multicenter, prospective clinical trial called the SOMO•INSIGHT study now underway to evaluate the sensitivity and specificity of digital X-ray mammography combined with U-Systems' somov automated breast ultrasound system in women with breast tissue

of greater than 50 percent parenchymal density. Researchers hope to enroll up to 20,000 women over the next 12 months and publish the results in 2011.

"Automated breast ultrasound is very important for the early detection of breast cancer," says Ron Ho, president and CEO of U-Systems Inc. "Many tumors are missed today using the gold standard of mammography. X-ray is very effective for fatty breasts, but in dense breast tissue, X-ray does not resolve lesions well. Both dense breast tissue and lesions show up white on X-ray. Ultrasound doesn't have that problem."

For radiologists, automated ultrasound breast scanning also means significantly shorter data acquisition times and fewer sonographers suffering repetitive motion injury, says Jacqueline Bailey, RT, RDMS, global marketing manager for Siemens Medical Solutions, maker of the ACUSON S2000 Automated Breast Volume Scanner.

"Within a minute of manipulating an ultrasound transducer you can feel the strain on the wrist," Bailey says. "With automated ultrasound, the operator only needs to position it on the patient, press a button, and the machine automatically acquires views of the breast. Do this a few times, then take it to a workstation for a doctor to read the results."

Willing to pay

Regarding costs, many women are willing to pay out-of-pocket for automated ultrasound as a breast cancer screening tool, says Scott Huntley, executive vice president of business development for

SonoCiné. "An educated woman is empowered to make her own decisions," Huntley says. "Fifty percent of women to whom this is offered will pay up to $300 for it, based on a survey of more than 1,000 patients."

In addition, most patients consider the false positives associated with ultrasound an acceptable trade-off, says Jessica Guingrich, MD, a SOMO•INSIGHT researcher and medical director of the Susan G. Komen Breast Center, an affiliate of OSF Saint Francis Medical Center, Peoria, Ill. "The fact that ultrasound may lead to more follow-ups and more biopsies is, for many women, reassurance they are being followed more closely," Dr. Guingrich says. "Needle core biopsies are minimally invasive with, overall, very reassuring results."

To which Dr. Cappello, a cancer survivor and founder of www.areyoudense.org, asks simply: "What would you rather have: a biopsy that comes back negative or advanced cancer?"

References

1. Boyd, N., Guo, H., Martin, L., Sun, L., et al. (2007). Mammographic density and the risk and detection of breast cancer. NEJM, 356(3), 227-36.

2. Berg, W., Blume, J., Cormack, J., et al. (2008). Combined screening with ultrasound and mammography vs. mammography alone in women at elevated risk of breast cancer. JAMA, 299(18), 2151-63.

3. Kelly, K., Dean, J., Comulada, W. & Lee, S. (2010). Breast cancer detection using automated whole breast ultrasound mammography in radiographically dense breasts. Eur Radiol, 20(3), 734-42.

Michael Gibbons is a senior associate editor of ADVANCE.

Automated Breast Ultrasound Product Profiles

• Siemens Healthcare's ACUSON S2000 Automated Breast Volume Scanner

The ACUSON S2000 ABVS system is a multiuse, automated volume breast ultrasound system that automatically and quickly acquires full-field sonographic volumes of the breast. Benefits include streamlining workflow and reducing operator dependence and variability.

It also allows viewing of the anatomical coronal plane not available with conventional handheld ultrasound, and offers semiautomated BI-RADS reporting capabilities.

• U-Systems Inc.'s somo.v Automated Breast Ultrasound

Somo.v's 14.5-cm transducer acquires breast image data available in standard ultrasound formats and in 3-D reconstructed coronal view. With the wide field of view, the physician sees more breast tissue than with conventional ultrasound.

The images are immediately presented in an easy-to-read format for clinical display and review, making high-volume, cost-effective breast ultrasound imaging possible.

• SonoCiné Inc.'s Computer-Guided Whole-Breast Ultrasound

The SonoCiné computer-guided transducer images the entire breast, conforms to the breast (not forcing the breast to conform to the scan), measures and records transducer location in time and space, and calculates lesion location relative to the nipple.

The sonographer acquires images and records the complete exam, allowing total attention to the patient and eliminating interpretation distraction. The exam is ready to read in five to seven minutes.