Breast Cancer continues to be the leading cause of non-preventable cancer death among American women. More than 40,000 women die annually from breast cancer in North America.

The imaging method used to diagnose breast cancer is the mammogram, which involves radiation. Ultrasound and MRI are important supplementary imaging methods in the study of breast pathology. All of these methods detect anatomical changes. Some investigators have suggested that thermal abnormalities occur 8 to 10 years earlier than mammography can detect anatomical changes.

Thermal imaging methods, namely thermometry and radiometry, detect pathological processes by changes in tissue temperature. Radiometry has been developed in Russia for the last 20 years. In 1997 radio-thermometry (RTM) a computer-based radiometer was developed. There are several potential advantages of RTM over other diagnostic methods in detecting early breast pathology.

Our main objective is to validate RTM as a diagnostic tool and compare its output to more conventional imaging methods.

Research Design:; Selected subjects will be asked to volunteer for the study. With consent, an RTM will be performed on every patient who will undergo either precutaneous or surgical biopsy based on abnormalities detected by either mammogram or ultrasound. This study will be carried out for 2 years. In this period we will have about 200 patients with mammography and ultra-sound positive results.

For estimating specificity and sensitivity RTM will be performed on 300 high risk patients with negative mammography and ultrasound results as well. If any of these patients having RTM positive result, a follow up will be done with mammography and ultrasound after 6 months. If the result is negative, a routine screening will be done after 18 months. RTM also has the potential of being a useful non- invasive imaging method to monitor effectiveness of treatment. A supplementary protocol has been designed to follow periodically patients that will be treated with chemotherapy. RTM is a method with multiple potential benefits in the study of breast pathology and particularly in detection of breast cancer. It is harmless and can be applied to women of all ages, can be performed repeatedly without the use of radiation. The unit is small, portable and very simple in operation therefore can be performed by secondary medical personnel in remote places.