由 Lisa Chamoff
, Contributing Reporter | July 01, 2019
From the July 2019 issue of HealthCare Business News magazine
The current FDA clearance allows the Koning KBCT to be used in place of a diagnostic mammographic workup, said David Georges, president of the company’s USA division. The device can also be used to perform a 3D-guided biopsy in place of conventional stereotactic biopsy. The FDA cleared the biopsy application at the same time as the main system.
The company is currently working on development of a breast CT system, dedicated to screening the breast with a complete 360-degree acquisition, delivering true 3D, isotropic image data, Georges said. The prototype is due to be ready for testing at the end of 2019.
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Additionally, as contrast-enhanced CT imaging has long been used to detect cancer in the head, chest and abdomen, Koning is sponsoring clinical studies examining the use of contrast-enhanced CT imaging for detecting small cancers that may not be detectable with conventional mammography or tomosynthesis breast imaging.
“We’ve gained much information in relation to contrast-enhanced breast CT, which is leading us to believe we will make new strides in separating the various patient populations that will be based on a combination of risk factors, including breast density and family history,” Georges said. “A breast CT on a patient that has low to average glandular density could be achieved quite successfully with one low-dose CT acquisition without contrast. For those patients with greater breast densities, the potential of including contrast-enhanced breast imaging should serve to detect cancers at very early stages.”
Institutional review board studies are underway for contrast-enhanced CT and the company expects results to be published in late 2019 or early 2020.
The FDA indicated that the diagnostic dose for breast CT from Koning is in the same range as the dose for digital breast mammography which was one of the factors that lead to the FDA PMA clearance, according to Georges.
“One of the most noteworthy features of Breast CT is the removal of painful compression, a frequent complaint from many patients today receiving mammograms,” Georges said. “Moreover, the inclusion of isotropic 3D imaging will provide image data sets currently unavailable from any other X-ray emitting breast imaging device.”
Kubtec recently introduced an extension of its MOZART System, an intraoperative tomosynthesis scanner designed to provide 3D images of specimens during lumpectomies. Called the MOZART Supra, it is designed with a larger detector to image larger specimens, so it can be used for mastectomies as well as lumpectomies.