Diagnostics & Imaging Week Contributing Writer

BALTIMORE – The American Society of Breast Surgeons (ASBS; Columbia, Maryland) represents the fastest growing surgical subspecialty group in healthcare, with 2,400 members and strong membership participation at each annual meeting. It could boast an estimated 40% attendance at its annual meeting held here earlier this month.

According to ASBS past president Peter Beitsch, MD, director of the Dallas Center for Breast Care (Dallas, Texas), "Trials form the basis of treatment," and this group of leading-edge surgeons believes that clinical trials belong in private practice as well as in the academic setting.

For these forward-thinking surgeons, the meeting offered a wide range of futuristic technologies for imaging and treating breast cancer.

The systems used for imaging the breast for early scanning purposes – such as bioelectrical impedance and palpation imaging – are especially intriguing in their promise for augmenting, or perhaps eventually supplanting, mammography.

Several companies are addressing the front end of the continuum of breast care by attempting to screen a broader range of patients prior to mammography, thereby "casting a wider net" in order to include patients who otherwise might not be screened for breast cancer.

Z-Tech Medical (Westford, Massachusetts) exhibited its radiation-free breast scan which utilizes an array of electrodes placed over each breast to measure the impedance across them – comparing the electrical currents in the same place on one breast with the identical electrode placed on the other.

When an area of the breast becomes malignant there is an increase in the volume of fluid in the region and the cell membrane becomes electrically porous, both changes resulting in a decrease in electrical impedance in the cancerous area. Thus, in this system a set of electrodes is placed on each breast, and an imperceptible electrical current is passed through various pairs of electrodes. A difference in electrical signals given off by one spot on one breast as compared to its "twin" spot on the other is an indicator that there may be something suspicious in that area.

This test is designed for screening to detect cancers very early when treatment is most effective and least invasive. It is for screening only, so that when a patient has a suspicious result she is directed to a radiologist for a mammogram.

Two other companies not present at this meeting, have FDA clearance of similar products: Mirabel (Austin, Texas) and Siemens Medical Systems (Malvern, Pennsylvania). A differentiating feature is that Mirabel and Siemens produce an image, whereas Z-Tech only states which quadrant on which breast requires closer examination. The beauty of all three companies' systems is that they are radiation free, hence not requiring shielded rooms, shielding for patients and staff, and the other infrastructure encumbrances required by X-ray. And the bio-impedance scanning modality does not require a licensed X-ray tech nor operator certification or licensure, making it ideal for a doctor's office.

Add to these advantages, lower cost and no breast compression and one has a formula to reach the 40% of eligible patients who currently do not get their annual mammograms.

Also present at the meeting, along the lines of pre-screening, was palpation imaging for the clinical breast exam.

Leslie Jacobson, MD, Bellingham Breast Center (Bellingham, Washington) made a presentation titled "Digital Documentation of the Physical Breast Examination: Moving the CBE to the EMR." He explained that "despite improvements in breast imaging, documentation of the clinical breast exam [CBE] has remained unchanged since the last century."

He described a new device manufactured by Medical Tactile (Los Angeles) that electronically documents clinical breast exam results. The portable system is based on proprietary tactile sensing technology that enhances and quantifies the doctor's sense of touch during manual palpation during breast cancer screening.

Using a hand-held tactile probe that employs highly sensitive sensors that map lesions as small as 5 mm, Jacobson claimed he "was able to translate the clinical breast exam into digital format that records the physical characteristics of the clinical findings in a consistent and reliable fashion, with the intent of improving communication between surgeon and his referral base."

This is important. The majority of breast-cancer related lawsuits come from those circumstances where the patient felt she had a lump at a time when the surgeon said no lump existed.

Thus, with palpation imaging an objective record of palpable findings will be documented should any medical legal issue arise at a later date.