New imaging device from TransScan holds promise in breast imaging

Israeli company is placing T-Scan at beta sites

An investigational medical imaging technology based on the measurementof electrical impedance properties in healthy and cancerous tissuemay serve as a low-cost yet diagnostically powerful adjunct tomammography. It could improve the early detection of breast tumorswithout exposing patients to x-ray radiation. Further down theroad, this tumor-detection technique might have noninvasive orintraoperative applications in other parts of the body, such asthe prostate, brain, liver, and skin.

Four clinical sites are up and running in the U.S. to evaluatethe noninvasive T-Scan breast imaging system for TransScan Researchand Development of Migdal Ha'Emek, Israel. The latest clinicalsite, Emanuel N. Maisel Women's Health Center for Breast Carein West Bloomfield, MI, was brought on board last month.

TransSpectral Impedance Scanning, which is TransScan's trademarkedterm for the technology, is similar to ultrasound in that it isperformed in real-time, said Andrew Pearlman, founder and chiefscientist of TransScan. The most important difference, however,is that T-Scan transmits and detects a very low voltage electricalsignal into the body rather than an ultrasound signal. The devicethen uses the measurement of changes in the signal to map outdifferences in electrical resistance and capacitance in the tissue.

"It (the map) looks similar to a nuclear medicine image,"Pearlman told SCAN. "The morphological shape is not necessarilypreserved but location and so forth are indicated. The devicedetects the characteristic changes that occur in normal breasttissue when it is transformed to a neoplasm. It looks for changesin membrane properties, in particular those that reflect a differencein capacitance, and changes in the permeability of that membraneto fluid flow, which are reflected in conductivity."

T-Scan has been approved by the Israeli Health Ministry, andcommercial sales have commenced in that market, Pearlman said.Orders are also coming from markets in Europe and Asia. TransScanhopes to file for commercial certification by the Food and DrugAdministration early next year.

Preliminary studies in Israel indicate that T-Scan has highsensitivity (accuracy in diagnosing cancerous tumors) as wellas specificity in determining benign lesions, he said. If supportedby outcomes in the current clinical studies, T-Scan's accuracy,as well as its ability to scan the entire breast, could enableusers of the device as a mammography adjunct to reduce the numberof biopsies due to false-positive diagnoses.

Future clinical trials may study the utility of this technologyas a breast cancer screening device. T-Scan is being used in Israelto screen younger women, Pearlman said.

T-Scan may have a future in the cost-conscious U.S. market.The device is less expensive than mammography, both in terms ofcapital and procedural costs, he said. T-Scan's image is alsoeasier to read than mammography or ultrasound images, which couldreduce training costs.