Spinoff company receives $2.5 million NIH grant to build prototype scanner

05/11/05

Potential to change medical practice in breast imaging

Koning Corp., a Rochester-based imaging start-up, today announced that it has received a $2.5 million grant from the National Institutes of Health (NIH) to build a next-generation scanner for the early diagnosis of breast cancer, image-guided therapeutics and breast cancer screening. Cone Beam Computed Tomography (CBCT) has the potential to consistently find tumors before they become incurable, according to Ruola Ning, Ph.D., founder of Koning and a professor in the University of Rochester Medical Center (URMC) Department of Radiology.

Early detection and removal of tumors is the key to reducing cancer deaths. Researchers have been trying for decades to consistently identify malignant tumors between one and two millimeters in diameter. Doing so affords patients a more than 90-percent chance of survival, but many breast cancer patients today have tumors that are incurable by the time they are found. More than 40,000 U.S. women will die from the disease in 2005.

"Small disease is curable disease," Ning said. "In pre-clinical trials, Cone Beam CT detected with certainty tumors between one and two millimeters in diameter, while standard mammography had trouble accurately detecting tumors ten times that size."

When a malignant tumor reaches about 2 mm in size, two deadly events occur: angiogenesis and metastasis. Angiogenesis is the formation of new blood vessels that supply the nutrients tumors need to grow. With the newly formed vessels in place, cancer cells that break away from the tumor can circulate through the body to seed cancer elsewhere (metastasis).

Conventional mammography, little different than technology developed in the 1950s, spots a tumor at 11 millimeters in diameter on average. The problem is that the technology attempts to capture the image of a three-dimensional object on a two-dimensional detector. In the resulting images, small tumors located in the middle of the breast may be lost among the overlapping layers of healthy tissue above and below (structural overlap).

"CBCT eliminates structural overlap for a clearer view of early tumors," Ning said. "At the same time, the prototype machine captures images by rotating around the breast, not by flattening, or compressing, it in the painful way required in conventional mammography."

CBCT consists of an ergonomic exam table that isolates the breast, a novel cone beam X-ray source, a detector that captures more information as it circles the breast and patented software that allows for better 3-D imaging. Ning's apparatus also achieves the improved imaging at or below the radiation dose used in conventional mammography.

The improved 3-D accuracy and lower radiation seen with CBCT may also help to realize the potential of image-guided therapeutics or surgery. In the future, highly accurate scans may enable surgeons to instantly confirm that a surgery has succeeded. As it stands, many patients must return for a second surgery when pathology slides reveal that the first procedure missed some of the tumor.

Koning's latest NIH grant, a Small Business Innovation Research (SBIR) Award, brings investment in Cone Beam CT technology to nearly $11 million and sets the stage for human clinical trials on its effectiveness. In the near term, Koning has agreed to partner with local electronic component companies to build the first CBCT scanner prototype. Excell Partners, Inc., formerly University Technology Partners (UTP), Inc., and the University of Rochester Medical Center Office of Technology Transfer have worked closely with Ning to begin commercializing CBCT. URMC has invested $300,000 to provide CBCT patents, and has licensed the technology to Koning to make, use and sell CBCT scanners. Excell, a non-profit corporation formed to help URMC researchers start businesses, has worked to gain access to investment capital, and also today announced that it will invest an additional $25,000 in Koning for business strategy development.

"The next step for Koning will be to seek funding to conduct CBCT clinical trials over the next 18 to 20 months for a mammography indication," said Mark Scheuerman, chief operating officer at Excell Partners. "If all goes well with the trials, the company will then seek marketing clearance from the U.S. Food and Drug Administration."

Key consulting partners in the development of CBCT included:

  • Jeanne Cullinan, M.D., director of Women's Imaging at URMC
  • Wende Logan Young, M.D., director of Rochester's Elizabeth Wende Breast Clinic
  • David Conover, M.S., lead author of the SBIR grant and research associate within the URMC Department of Radiology
  • Gretchen McGuire Ahrendt, M.D., director of Breast and Endocrine Surgery at URMC
  • Linda Schiffhauer, M.D., assistant professor of Pathology and Laboratory Medicine at URMC

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