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

This study has been completed.
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Dr. Julia Knight (research collaborator)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188760
First received: September 9, 2005
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optical Quantification of Breast Density Changes Due to Hormone Treatment, Pregnancy and Breast-feeding.

Resource links provided by NLM:


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

Enrollment: 300
Study Start Date: May 2004
Study Completion Date: September 2010
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

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders 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)

Criteria

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
  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: NCT00188760

Locations
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)
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, Ontario, Canada M5G 2M9
  More Information

Publications:
Responsible Party: Dr. Lothar Lilge, University Health Network
ClinicalTrials.gov Identifier: NCT00188760     History of Changes
Other Study ID Numbers: UHNREB#02-0712-C, SGKBCF#BCTR0402530, MSHREB#02-0226-E, UTREB#9313, HC#69745
Study First Received: September 9, 2005
Last Updated: October 6, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 18, 2014