In an industry dominated by traditional mammography systems, alternative breast imaging device developers face the challenge of proving that their technology could offer important benefits mammography scans do not. Since the early 1990s, more and more
In an industry dominated by traditional mammography systems, alternative breast imaging device developers face the challenge of proving that their technology could offer important benefits mammography scans do not. Since the early 1990s, more and more firms have begun developing noninvasive methods of breast imagingdesigned to be used as adjuncts to mammographywhich they hope will revolutionize the way breast cancer is detected by decreasing tissue compression and eliminating radiation, as well as improving specificity and sensitivity.
Joining the ranks of these alternative companies is DOBI Medical Systems, which debuted its investigational Dynamic Optical Breast Imaging (DOBI) unit at its first RSNA show in December. DOBI Medicals strategy is to position the product as a supplement to mammography that will reduce the number of benign biopsies performed by helping physicians make informed decisions about a womans need for biopsy after an inconclusive mammogram.
DOBI Medical has its roots in a company called Dynamics Imaging, established in 1994 to commercialize DOBI technology developed at the Russian Academy of Sciences in Moscow during the 1980s. Last year, Dynamics Imaging lost its financial viability, and in August sold its assets to DOBI Medical Systems, a new company created by CEO Phillip Thomas and private investment firm Lakeworth Ventures of West Palm Beach, CA. Based in Mahwah, NJ, DOBI Medical Systems has a U.S. staff of eight employees, as well as a technical team of 10 researchers in Moscow, where the companys clinical and product development takes place.
In a DOBI exam, the patient stands upright, and the breast is placed in a holder that consists of a plate with an array of light-emitting diodes (LEDs) at the bottom and a curved latex membrane that conforms to the breast at the top. Light from the LEDs is transmitted through the breast tissue to a digital CCD camera that records the data. As the scan is being performed, the latex membrane alternatively exerts and releases roughly a pound of pressure on the breast tissue, which induces vascular changes that are then imaged. A computer processes the information and displays it as a real-time video image at one frame per second over approximately one minute.
What were looking for in a DOBI scan is vascular change as a result of external pressure, Thomas said. Cancer grows by a process of angiogenesis, the formation of vasculature. So were not looking for tumors with the DOBI system, but for the vascular development that arises from cancer. Tumor beds have increased blood supply (compared to normal tissue), and as the scanner applies pressure, the light transmitted is absorbed by (the tumor bed) differently than it would be in normal tissue.
DOBIs technology is different from transillumination, another light-based breast imaging technique being used by companies such as Imaging Diagnostic Systems (IDSI) of Plantation, FL, according to Thomas, because DOBI produces a dynamic, functional image rather than a single, static image.
Transillumination shows homeostasis, he said. Dynamic functional imaging goes a step beyond this to look at contextual images that change over time. Our technique is based on physiological measurement rather than static measurement. If theres cancer, there are going to be physiological changes, so we seek to provide external stimulus by exerting pressure on the breast tissue to reveal these changes.
The unit underwent clinical feasibility trials in 1996 at Columbia Presbyterian Medical Center in New York City and the National Research Center for Surgery in Moscow. At Columbia Presbyterian, an unblinded study was conducted with 22 women between the ages of 36 and 83 who were imaged over a nine-month period. The women were all candidates for breast biopsy, and biopsies were performed on 21 lesions in 18 patients. Using mammography, clinicians found malignancy in 16 lesions and benign pathology in five lesions. Subsequent DOBI scans found abnormality in 15 of the 16 malignant lesions, and detected four of the five benign lesions, which the company believes provides evidence of DOBIs potentially high specificity and sensitivity rates. Since 1998, the company has been conducting pilot studies at such institutions as Cornell University Medical Center, Hackensack University Medical Center, Massachusetts General Hospital, and Temple University Medical Center.
DOBI Medical Systems won the CE Mark for the product in May 1998. The firm plans to begin premarket approval trials in the fall, and to submit a PMA application to the Food and Drug Administration in approximately 18 months, according to Thomas. DOBI Medical expects to list its breast imaging device for half the price of traditional mammography units, and emphasizes the overall benefits of the system in technology, patient care, and cost.
Were looking at a product that is digital, provides real-time feedback, and eliminates the need for chemicals and lead-shielded rooms, in addition to potentially reducing the number of benign biopsies, Thomas said. It will probably cost significantly less than a mammography or ultrasound device. And DOBI could offer considerable savings to physicians and insurance companies, since it would be much cheaper to do a $300 DOBI scan than a $1000 to $5000 biopsy.