FISCHER IMAGING TO BEGIN DIGITAL MAMMOGRAPHY CLINICAL TRIALS
This article was originally published in The Gray Sheet
Executive Summary
FISCHER IMAGING TO BEGIN DIGITAL MAMMOGRAPHY CLINICAL TRIALS in early 1994, company Chairman and CEO Morgan Nields said at an Oct. 6 press conference in Washington, D.C. "We're actually moving towards getting the machines in the field for clinical use sometime early next year," Nields said. Prototype development is well underway, and the first system should be installed for clinical study early in 1994; the study will be expanded to at least four other sites during the year. The company anticipates submitting a 510(k) for the system at the end of 1994. The x-ray systems manufacturer is developing the new mammogram technology in conjunction with the Department of Energy's Lawrence Livermore Laboratory in Berkeley, California under a cooperative research and development agreement (CRADA) that was signed at the press conference. Fischer Imaging will devote $2.4 mil. to the $3.28 mil. defense-to-civilian technology transfer project and DOE will contribute the remaining $880,000. The two parties will contribute "nearly equally" during the initial R&D phase of the project, while Fischer will be responsible for clinical trials and the FDA approval process. The research partners predict that use of digital imaging technology will enhance image quality, which would improve diagnosis of the microcalcifications and masses in the breast that are signs of cancer. A digital system could "produce clearer images using less radiation," than conventional systems, "thus enabling earlier and more accurate detection of breast cancer and the saving of lives," DOE said in an Oct. 6 press release. Digital mammography employs electronic radiation detectors to translate x-ray energy into electronic signals; images would be displayed on monitors instead of being printed onto film. DOE, which had developed digital x-ray technology for military applications such as an x-ray laser system, estimates that radiation dose could be reduced by "at least a factor of two" with the new technology. One of DOE's responsibilities under the CRADA will be to optimize an x-ray source in which the dose can be adjusted for each patient. Although not part of the cooperative agreement, a digital system could eventually incorporate computers to enhance images and identify early signs of cancer, according to DOE. The technology also would "enable transmission of images over the nation's information highways," the agency remarks, which would "facilitate communication between radiologists on difficult cases." Fischer already uses digital technology in its Mammoscan stereotactic biopsy imager, which was introduced in November 1992 ("The Gray Sheet" Oct. 12, 1992, I&W-3). Digital mammography, however, requires a much wider field of view than biopsy imaging. One of the initial weaknesses of a digital mammography system could be the monitor, which is not capable of displaying the 4,000 X 5,000 pixel image generated by the system. Current technology would require radiologists "to diagnose from a monitor that's not as good as the information we're giving the system," Nields said. The digital mammography system would cost between $150,000 and $200,000, Fischer says, two to three times the cost of a conventional mammography system. Although the company acknowledges that health care provider cost constraints could pose an obstacle to acceptance of the technology, officials argue that it will be cost effective in the long run. "The initial cost of the equipment isn't a very large factor in the cost of a mammography exam," DOE explains. "Operating expenses will be lower" because film will not be used in most cases. Furthermore, "if superior image quality leads to earlier and more accurate diagnosis, then savings from fewer biopsies, less invasive surgery, reduced hospitalization and quicker return to work will result in a very large return on the investment in better detection technology," the agency contends. Sen. Barbara Boxer (D-Calif.), who hosted the press conference, hailed the technology as a "breakthrough in the fight against" breast cancer. Boxer noted that she is sponsoring legislation (S 1454) that "would provide greater funding for breast cancer research and encourage more young scientists to enter the field." The cooperative agreement with Fischer is one of several biomedical research efforts underway at Lawrence Livermore. In July, the laboratory entered a $15.2 mil. CRADA with Phoenix Laser Systems to develop an implantable "micro-thin lens" for diffractive correction of presbyopia, hyperopia, myopia and cataracts. The micro-lens would be "the first diffractive lens ever to be produced without significant color distortions." Other projects include improved versions of artificial joints, and high- resolution computed tomography for studying osteoporosis. In addition, the laboratory is doing R&D work on a mechanical heart valve for a medical device company.
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