Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.

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University Health Network, Toronto

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00188682
UHNREB#00-0081-C
DOD#DAMD17-00-1-0393
UTREB#5507

Details and patient eligibility

About

The purpose of this study is to learn more about the application of transillumination measurements in the determination of breast cancer risk. The goal is to demonstrate a correlation between non-invasive optical transillumination spectroscopy and parenchymal density pattern.

Full description

X-ray generated images, such as mammograms, rely on the density of tissue within the breast. Tissue density are believed to be associated with proliferation of stroma and/or epithelium, which result in an increase in water associated light absorption and a decrease in lipid associated light absorption. The amount of density of the breast tissue has been shown to be an indicator of cancer risk. Thus, assessing this breast tissue density is also an important tool in determining breast cancer risk. Optical transillumination has been shown to give information about tissue composition and tissue density. Unlike x-ray mammography which uses ionizing radiation, optical transillumination uses normal white light and is deemed safe to be used frequently for women of all ages and therefore can be used for those situations where mammography is not an option. Normal white light is shone into the tissue and the light that leaves the breast on the other side from the source is detected and analyzed. Since the same physiological conditions that contribute to dense breast tissue, as seen in mammography, also will have unique optical signatures. We will compare the amount of this dense tissue from the mammogram, taken with 12 months, to the density measurements found through the optical procedure. The goal is to be able to duplicate the information from the mammogram using the transillumination technique. All measurements are non-invasive and no blood samples or biopsies are required.

Enrollment

300 patients

Sex

Female

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Be in good health and able to provide consent
  • Be between 35 and 75 years of age
  • Have no personal history of breast cancer
  • Have had a mammogram at The Marvelle Koffler Breast Centre at Mount Sinai Hospital within the last 12 months

Exclusion criteria

  • Have had breast biopsy
  • Have had breast augmentation or reduction

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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