CTI Completes Patient Data Collection
Phase of Breast Cancer Clinical Trial
LAYTON, Utah, Oct. 24 /PRNewswire/ -- Computerized Thermal Imaging, Inc. (CTI) (OTC Bulletin Board: COII - news) announced today that it has completed the patient data collection segment of its clinical trial which is required for Module 5 of the Company's FDA Pre-Market Approval Application. The results of the clinical trial will be used in Module 5 to demonstrate the effectiveness of the CTI Breast Cancer System in recognizing and differentiating temperature patterns of malignant and benign breast tumors.
``I am very pleased to have finished this part of the clinical trial,'' stated David Packer, Company president. ``This accomplishment represents years of work and is a significant milestone. Although we have enough patient data to finalize Module 5, we will continue to collect patient data at each of our five clinical sites in case additional data is needed at a future time. The contract with each of these sites provides them the option to convert to normal revenue based clinical usage if FDA approval of the CTI system is received. The collected data is now being analyzed and compiled in preparation for submitting Module 5 to the FDA for review. Although FDA approval cannot be assured, preliminary clinical trial results look promising.''
Regular self-examination and scheduled mammograms are vital to ensure a woman's health. However, as indicated in a study published by the New England Journal of Medicine, the frequent occurrence of false positive diagnoses resulting from mammograms is a concern. The study reports that the estimated cumulative risk of a false positive diagnosis was 49.1 percent after 10 mammograms and that among women who do not have breast cancer, an estimated 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).
In its clinical trial, CTI has been examining women who have been scheduled for biopsy as a result of a suspicious lesion discovered through a mammogram and/or a clinical examination. By using its sophisticated image analysis algorithm, CTI is able to derive thermal characteristics of breast tissue being examined. These thermal characteristics provide insight into the operation of a woman's vascular system and the physiological processes occurring within the breast tissue. The purpose of the clinical trials is to confirm the capacity for CTI's technology, used in conjunction with clinical examination and/or mammography, to enhance a physician's ability to make the diagnosis between benign and malignant breast tissue and reduce the number of biopsies currently thought to be necessary. The procedure is painless, non-invasive, and requires no exposure to radiation, breast compression, electrodes or electrical current.
Computerized Thermal Imaging, Inc. is in business to improve the quality of life through the development and deployment of thermal imaging and associated technologies. Information about CTI can be found at www.cti-net.com on the Internet at or by calling CTI Public Affairs at 801-926-1113. |
