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Clinical Trial Summary

Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Although the reason for this has not yet been demonstrated, this stability may be a direct consequence of early detection and improved therapy. Screening mammography as an early detection technique has been shown to reduce mortality by 23%. Mammographic abnormalities that go on to biopsy show 24% being positive for malignancy with great variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and surgery which may be obviated by more specific non-invasive testing.


Clinical Trial Description

Diffuse Optical Spectroscopic Imaging a new method for quantitative characterization of the optical properties of tissues. The diagnostic tools utilize anomalies in the transmission of diffusing near infra-red light for the rapid detection of oxygenated and deoxygenated hemoglobin, near infra-red absorbing drug levels, blood volume changes, and scattering properties in tissues. Diffuse Optical Spectroscopic Imaging measurements of breast tissue optical properties probe is similar in shape to an ultrasound probe. The imaging can measurements on different areas of the breast including diseased location and normal area. Optical measurements can guided by co-registered ultrasound measurements for the purpose of determining lesion size and location. Each measurement will require about 5-60 seconds to record the data and calculate optical properties. The process will be repeated until an adequate number of measurements are performed and measurements take 30 to 90 minutes. The researcher can determine that breast optical properties on demographic information, such as age and menopausal status as well as medical history. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00540540
Study type Observational
Source University of California, Irvine
Contact
Status Withdrawn
Phase
Start date December 1995
Completion date July 2018

See also
  Status Clinical Trial Phase
Completed NCT00540306 - Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy
Withdrawn NCT01773551 - Development of a Quantitative Tissue Optical Index of Breast Density For Prediction of Hormone Therapy Response