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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00188760
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Completion: 2010-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Ontario Cancer Institute, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada