Laser System, Dedicated Breast Scanner Show Promise As Adjuncts

Mammography is far from perfect, and a range of techniques may serve in a supporting role to this omnipresent but notoriously fallible breast cancer screening tool.

One of the newest to appear on the scene is conebeam CT, which gathers volumetric data using a digital flat-panel detector packed into a small-parts imaging unit. Three-D images display 360 degrees worth of breast anatomy, up to 300 images, with no more radiation than a two-view mammography scan.

The University of Rochester in New York developed and patented a conebeam CT system for breast imaging. The university installed a clinical version of the dedicated breast unit in June.

Commercial release of the scanner is uncertain as FDA requirements for approval are not yet known. Initially, the system will be used to assist diagnosis and not for breast screening. For this purpose, requirements are expected to be less stringent. The price will be $700,000 to $800,000.

"We don't feel a large-scale trial is required as we are not going for screening," said John Neugebauer, CEO of the Koning Corporation.

The company has been commercializing the unit with the help of more than $8 million in grants from the National Institutes of Health.

CT laser mammography (CTLM), another supportive technique, is able to detect greater blood flow, which is a sign of cancer, with a radiation-free energy source.

At the 2006 ECR, Dr. Daniel Flory, a radiologist at the University of Vienna, presented encouraging results after evaluating 410 patients with 421 breast lesions with a CTLM system. The overall sensitivity and specificity were 66% and 63%, respectively. The sensitivities for invasive and noninvasive carcinoma were 73% and 49%, respectively.

"The results are comparable to other adjunctive techniques," Flory said.

The researchers used a laser device from Imaging Diagnostic Systems in Plantation, Florida. It is commercially available in Europe, Canada, and the Middle East but does not have FDA approval for use in the U.S. The manufacturer aspires to make its domestic debut in 2007.

Elastography, an ultrasound-based method of measuring the elastic property of tissue, is getting a fresh look. At the ECR, researchers from Britain and France showed the efficacy of the technique. They said it could reduce the rate of biopsies of benign breast lesions, whose elastic property is not as stiff as malignant tissue.

Siemens Medical Solutions is planning the commercial release of an elastography-enabled system later this year.