Massachusetts General Hospital to Begin Clinical Study on Breast Imaging System from Computerized Thermal Imaging PORTLAND, Ore., Aug 21, 2002 /PRNewswire-FirstCall via COMTEX/ -- Computerized Thermal Imaging (CTI) (Amex: CIO) announced today that Massachusetts General Hospital (MGH) will conduct a clinical study to help evaluate the company's breast imaging system. The system utilizes non-invasive thermal imaging technology that could help physicians differentiate between a patient's benign or malignant breast lesions. The study will begin in the fall and will be led by Dr. Kevin Hughes, MGH surgical oncologist, in association with Dr. Daniel Kopans, director of breast imaging at MGH and professor of radiology at Harvard Medical School. The initiation of this clinical study follows the announcement of two additional milestones for CTI's breast imaging system. The company has received notification from the U.S. Food and Drug Administration that a Radiological Devices Panel has been scheduled in October to review, discuss and make recommendations regarding CTI's Pre-Market Approval (PMA) application for its breast imaging system. In addition, the peer-reviewed medical publication American Journal of Roentgenology has accepted a clinical paper about clinical trial results of the breast imaging system for its January 2003 issue. "We believe that MGH has a responsibility to evaluate new technologies that might benefit our patients. The Breast Imaging Division has always been interested in the latest innovations in breast cancer detection and diagnosis," said Dr. Kopans. "Many lesions are detected by mammography or clinical examination that make us worry, resulting in a biopsy that proves to be a benign finding. We look forward to studying CTI's breast evaluation system as a method to help reduce the need for some of these biopsies." "Our primary commitment is to provide the highest quality care for our patients. CTI's breast imaging system is an advancement that could help us further that commitment," said Dr. Kevin Hughes, a lead investigator for the study. "We are continually looking at new methods and technologies to improve breast cancer detection and look forward to reviewing CTI's system." As Harvard Medical School's largest teaching hospital, Massachusetts General Hospital has the largest hospital-based research program in the country. This new breast imaging study has been designed to provide more information on how CTI's breast imaging system may be used following an abnormal mammogram. Today, surgeons typically perform a needle biopsy or a surgical biopsy of all suspicious breast tissue, and approximately 80 percent of these biopsies prove to be benign. This particular study will look at how CTI's breast imaging system could reduce the number of benign biopsies that are performed. "We are privileged to be working with the prestigious Massachusetts General Hospital, with its history and stature among the medical and research communities," said John M. Brenna, president and chief operating officer of Computerized Thermal Imaging. "We look forward to working with respected physicians, radiologists and clinicians like Dr. Hughes and Dr. Kopans to gather additional clinical research about our breast imaging system." CTI has already conducted and completed clinical trials at six medical facilities for the Breast Cancer System 2100 in order to fulfill Pre-Market Approval (PMA) requirements outlined by the FDA. The facilities include USC/Norris Cancer Center in Los Angeles, Calif.; St. Agnes Healthcare in Baltimore, Md.; Providence Hospital in Washington, D.C.; Lahey Clinic Northshore in Peabody, Mass.; Mt. Sinai Medical Center in Miami, Fla.; and Los Angeles County Hospital in Los Angeles, Calif. The study at MGH is the latest in CTI's ongoing research and the second study the company has commissioned since completing the aforementioned clinical trials. The first study was conducted at McKay-Dee Hospital Center in Ogden, Utah. A New Way to Examine Breasts CTI's breast imaging system is an investigational device, pending FDA approval as an adjunct to mammography, and is currently not available for sale in the United States. The company believes its thermal breast imaging system could provide an accurate and non-invasive way to assist physicians in distinguishing between benign and malignant lesions, thereby preventing some benign surgical breast biopsies. The system uses thermal imaging technology to provide a physiological profile of the breast, in contrast to the anatomical profile provided by mammogram x-ray. The system is non-invasive and requires no patient exposure to radiation, breast compression, or electrical current. About Computerized Thermal Imaging, Inc. Computerized Thermal Imaging develops and markets thermal imaging and associated technologies. CTI is focused on a few specific medical and industrial imaging opportunities. CTI markets two FDA-approved pain management products: a diagnostic infrared camera and an infrared light therapy device called the Photonic Stimulator. The company is awaiting FDA approval on an investigational device for thermal imaging of the human breast. Finally, CTI deploys its thermal imaging technology for an application that analyzes engine turbine blade defects. Source: Press Release CTI, 8/21/02 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.