Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188682
First received: September 9, 2005
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Optical Transillumination Spectroscopy of Breast Tissue in Pre- and Post-Menopausal Women.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Enrollment: 300
Study Start Date: March 2000
Study Completion Date: September 2003
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cohort recruited from the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto, Ontario, Canada)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188682

Locations
Canada, Ontario
Ontario Cancer Institute, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Lothar Lilge, PhD Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00188682     History of Changes
Other Study ID Numbers: UHNREB#00-0081-C, DOD#DAMD17-00-1-0393, UTREB#5507
Study First Received: September 9, 2005
Last Updated: November 13, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Optical Transillumination Spectroscopy
Transillumination Breast Spectroscopy
Breast Cancer Risk

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014