Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188760
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 7, 2011
Susan G. Komen Breast Cancer Foundation
Dr. Julia Knight (research collaborator)
Information provided by:
University Health Network, Toronto

Brief Summary:
The purpose of this study is to test the ability of a technique called Transillumination Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.

Condition or disease
Breast Cancer

Detailed Description:
Breast density is an established physical risk factor for breast cancer, applicable to the entire female population in a pre-breast-screening program and, unlike other risk factors, was shown to be affected by an intervention treatment. High breast tissue density is associated with increased risk of breast cancer. Transillumination Breast Spectroscopy (TIBS) uses a white light to provide spectral information on breast tissue density and composition (e.g. water, lipid, hemoglobin and other biomolecules). The overall goal of the TIBS program is to develop a technique that can identify individuals at high risk for breast cancer who would benefit most from improved screening methods and a risk reducing intervention (e.g. diet and lifestyle changes) and can monitor the efficacy of the risk reducing intervention itself in an individual. In a previous study, we demonstrated a high correlation between breast density assessed by TIBS and density identified by x-ray mammography. The current study is testing TIBS ability to monitor changes in an individual's breast density over time

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optical Quantification of Breast Density Changes Due to Hormone Treatment, Pregnancy and Breast-feeding.
Study Start Date : May 2004
Actual Study Completion Date : September 2010

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cases recruited from the Reproductive Biology Unit at Mount Sinai Hospital and the University Health Network community. Controls recruited from University Health Network community and the University of Toronto community. (Toronto, Ontario, Canada)

Inclusion Criteria:

  • Be in good health and able to provide consent
  • Be between 25 and 45 years of age
  • Be pre-menopausal
  • Are willing to come in to Princess Margaret Hospital (Toronto, Ontario, Canada) for up to 12 visits at intervals of about three months

Exclusion Criteria:

  • Have had a full term pregnancy
  • Have had breast biopsy
  • Have had breast augmentation or reduction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188760

Canada, Ontario
Ontario Cancer Institute, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Susan G. Komen Breast Cancer Foundation
Dr. Julia Knight (research collaborator)
Principal Investigator: Lothar Lilge, PhD Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Ontario, Canada M5G 2M9