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

Optical Transillumination Spectroscopy of Breast Tissue in Pre- and Post-Menopausal Women.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00188682

Enrollment

300

Registered

2005-09-16

Start date

2000-03-31

Completion date

2003-09-30

Last updated

2007-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Optical Transillumination Spectroscopy, Transillumination Breast Spectroscopy, Breast Cancer Risk

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 75 Years

Healthy volunteers

Yes

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

Countries

Canada

Outcome results