JULY 1st. BULLETIN FROM CTI'S HOME PAGE!
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Special Bulletin
Computerized Thermal ImagingT vs. ImageChecker
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(July 1, 1998) CTI has received a number of inquiries regarding the approval this week of the ImageChecker computer system by the FDA . The most frequently asked question is how does the ImageChecker compare in technology and function to Computerized Thermal Imaging.
The underlying technology of ImageChecker is different than Computerized Thermal Imaging. Simply speaking, ImageChecker is a refinement to the reading of traditional mammograms. Mammograms, as with all X-RAY based examinations, show anatomy, or "structure", such as bones, muscle and other dense tissues. Computerized Thermal Imaging is a fundamentally different imaging modality. It produces an image based on the heat radiating from the body. This image shows physiology, or "function", such as operation of the circulatory system, thermal regulatory systems and autonomic nervous system of the body. As currently used for breast cancer detection, both types of images are useful because they show different attributes of the breast: structure vs. function.
ImageChecker is a computer system designed to be a "second reader" of mammograms. The mammography images are scanned by the computer then evaluated for patterns that indicate suspicious areas. These suspicious areas are highlighted for the physician for re-evaluation. In recent news articles, Dr. Susan Alpert, Director of the FDA's office of Device Evaluation indicated that mammography misses about 20% of cancers. The FDA estimates that the device could increase a radiologist accuracy from detecting 80 of every 100 cancers to catching 88 of 100.
Although the helpfulness of ImageChecker is still being debated by some, it has the clear potential to catch more suspicious lesions which could increase the number of biopsies performed. The FDA cautioned that it is not clear if the device will increase false alarms and ordered the manufacturer to immediately begin studying that. The potential of more biopsies will increase, if anything, the need for a tool to decrease false alarms. CTI's clinical trials are aimed at reducing false alarms. Our trials are designed to confirm our preliminary results and to demonstrate it's potential to increase the ability of physicians to differentiate benign and malignant tissue. This will reduce the number of biopsy procedures, which can save women from the physical and emotional stress associated with surgery, while affording substantial savings to the health care system. The CTI examination is painless and requires no exposure to radiation or breast compression.
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