TechniScan, a medical device company developing an automated 3D breast ultrasound imaging system, has launched a clinical center in Rochester, Minnesota, its third new clinical site for its Warm Bath Ultrasound (WBU) system.
TechniScan’s WBU system is designed to capture three-dimensional images of the breast as a woman lies prone on a table and ultrasound technology is used in a warm water tank to image the breast anatomy. WBU provides information and breast images unlike any ultrasound systems on the market.
TechniScan said that it has scanned over 800 women in clinical studies in Salt Lake City and Ogden, Utah as well as Orange and San Diego, California. The past clinical studies focused on key factors like image quality, repeatability, and establishing protocols for testing baseline values for positive and negative predictive capabilities of the system.
According to Dr John Klock, TechniScan’s chief medical officer, the most recently completed clinical work continues to support that refraction-corrected reflection images highlight connective tissue features within the breast, whereas the speed-of-sound images show fibroglandular, ductal and terminal lobular units with high resolution.
Image consistency and reproducibility, whether it is weeks, months or a year between exams, are critical to support precise and reliable assessment of breast lesions. Clinical studies in San Diego recently evaluated the ability of the system to reliably reproduce images from the same woman.
The current clinical studies in Freiberg, Germany, San Diego and Rochester expects to involve at least 500 women with various types of breast lesions. The 12-month study compares WBU to conventional breast sonography and MRI as well as to examine the WBU’s ability to differentiate between normal, benign and malignant breast tissue. The clinical studies in the US are funded by a Small Business Innovation Research Grant (SBIR) from the National Cancer Institute.
David Robinson, president and CEO of TechniScan, said: “We have clearly demonstrated that the system can reliably reproduce images based on reflection and sound transmission and that those images will have significant clinical utility.”
Michael Andre, adjunct professor of radiology and director of medical physics at University of California, San Diego School of Medicine, said: “Volumetric whole-breast imaging provides a substantial practical advantage over conventional very-small-field-of-view sonography. We are greatly aided by the ability to produce repeatable whole-breast comparisons left to right and present to past. These comparisons are the nuts and bolts of breast imaging, by any modality.”