the 4/20 update from CTI
(April 20, 1998) CTI has received a number of inquiries asking if it was our study that was mentioned on a recent broadcast of FOX News in Southern California or if our clinical trials address the issues reported in that broadcast. The broadcast was reporting on the results of a ten-year study on the risks of a woman receiving a false positive result from a screening mammogram. In the broadcast, Dr. Yuri Parisky commented on the study and spoke of a clinical trial that he was involved with that was designed to address the issues raised by the study. The clinical trial referred to is the clinical trial of CTI's 80% owned subsidiary, Thermal Medical Imaging Inc. (TMI) underway at the Norris Cancer Center in Los Angeles and other locations.
The results of the study, published this week in the New England Journal of Medicine, has been widely reported in both print and broadcast media. The study reported that the estimated cumulative risk of a false positive result was 49.1 percent after 10 mammograms. The study further estimates that among women who do not have breast cancer, 18.6 percent will undergo a biopsy after 10 mammograms. The study concludes: "Over 10 years, one third of the women screened had abnormal test results requiring additional evaluation, even though no breast cancer was present. Techniques are needed to decrease false positive results while maintaining high sensitivity." (New England Journal of Medicine, April 16, 1998, Volume 338, pages 1089-1096).
The occurrence of false positive results is a major concern to women and their physicians. When an abnormality is detected by mammography or clinical examination it is often difficult for a physician to determine if it is benign or malignant. In our clinical trial, we examine women that have been scheduled for biopsy as a result of a suspicious mammogram and/or clinical examination. By using our sophisticated image analysis algorithms to process the digital data associated with each patient examination, we are able to extract thermal characteristics of the tissue being examined. These characteristics provide insight into the operation of the bodies vascular and autonomic nervous systems. These thermal characteristics represent the physiological processes occurring within the tissue. The vascularity and physiology of malignant tissue is different from benign or normal tissue. The purpose of our clinical trials is to confirm the ability of CTI's technology, used in conjunction with clinical examination and/or mammography, to increase the ability of physicians to differentiate benign and malignant tissue. If a physician has the tools to better differentiate benign and malignant tissue, fewer false positives will be diagnosed. |