The goal of this project is to continuously develop a novel cone beam breast computed tomography system (Koning CBCT 1000) into a clinically useful diagnostic breast-imaging tool and accelerate the FDA market clearance process to commercialize this cutting edge technology for diagnostic breast imaging. A commercial grade clinical scanner has been designed and constructed by Koning Corporation in compliance with international and national standards and regulations. Two pre-production prototypes have been installed at Elizabeth Wende Breast Care, LLC (Rochester, NY) and the Emory University (Atlanta, GA), for clinical trials and studies. The Koning CBCT 1000 system has passed electromagnetic compatiblity and electrical safety testing by a nationally recognized testing lab (Intertek) as required by the U.S. Food and Drug Administration (FDA). The novel features of the system are as follows, true isotropic high resolution without breast compression;equivalent or less dose than diagnostic mammography;equivalent or even better breast coverage than mammography;platform for future imaging-guided biopsy and possible dynamic contrast imaging and angiogenesis imaging with slip ring technology. It is anticipated that KBCT will have many technical advantages over mammography, including eliminating lesion overlap and removing superimposed structures (thus greatly simplifying the perception of breast tumors);providing a true 3D description of breast anatomy and lesions;providing accurate measurement of size, volume and density of breast tumors;and providing characterization of the borders, shapes and margins of breast tumors.
The specific aims of this project include: building and testing a KBCT image guidance subsystem for biopsy;redesign of the patient table to improve patient comfort and accommodate KBCT guidance subsystem for biopsy while maintaining breast coverage;the Company achieving ISO 13485 certification;bolstering Quality Assurance, production manufacturing, service and clinical training plans;performing clinical trials to prove the safety and effectiveness of KBCT that are equivalent to current diagnostic work-up (diagnostic mammography and ultrasound);and, most importantly, obtaining FDA clearance. After FDA clearance, the KBCT product will be launched with private resources.
Using no more than two or three sentences The relevance of this research to public health is an expected increase in accuracy for detecting cancer at an earlier size and stage and to obtain a more accurate assessment of the disease extent to reduce cancer burden to the patient. In addition, with this improved accuracy in detecting actual cancers, the potential exists to reduce the number of biopsy procedures ordered and reduce the number of benign biopsy findings.
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