Novato, Calif.-based QT Imaging, developers of the U.S. FDA-cleared QTscan, has completed a first-in-class and first-in-human study of transmission ultrasound as a new imaging technology for breast health screening. The recently published study in Academic Radiology found that, compared to full-field digital mammography (FFDM), transmission ultrasound showed increased sensitivity, increased specificity, and lower recall rates.
“This research represents an important milestone because it’s the first time a novel technology was compared to the standard of care in breast imaging in a primary breast cancer screening setting,” says John Klock, MD, CEO and chief medical officer of QT Imaging Inc. “While we are very encouraged by a 4% higher sensitivity, meaning the new modality can detect more lesions, the results of 16% higher specificity for transmission ultrasound is extremely promising.”
“To have the ability to know if a lesion is problematic or not can be a game-changer, resulting in reduced call backs, reduced biopsies, less anxiety for women, and perhaps even reduced healthcare costs,” Klock adds.
Transmission ultrasound is free of radiation, compression, and contrast injections, which makes it a safe, comfortable imaging experience for women of all ages. For younger women at high-risk for breast cancer, who do not qualify for x-ray mammography, it may provide a safer option that would allow them to have breast screening earlier and more often. QT Imaging will use this study, and additional ones, to secure FDA clearance for screening younger at-risk women under its FDA Breakthrough Device Designation.
While the published retrospective study shows that the inherently 3D nature of transmission ultrasound resulting in high resolution and high contrast-to-noise ratio makes it effective in evaluating breast tissue, a prospective study comparing true 3D transmission ultrasound to 3D breast tomosynthesis is warranted and will be published in the future. Based on learnings thus far, QT Imaging officials believe it is likely that transmission ultrasound will maintain its advantage in improved specificity and reduced callback rates.
Digital mammography has reduced mortality in the last couple of decades, but the industry now understands that interpreting mammographic images can be challenging in some scenarios, especially for women with extremely dense breasts. Advancements in the field will be welcome by healthcare professionals, imaging experts, and the women they serve, experts say.
