Breast Study to Learn More About the Application of Optical Transillumination Measurements to Assess Breast Cancer Risk and to Potentially Detect the Presence of Breast Cancer.

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00188721
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This study aims to evaluate if a light based technique, called Transillumination Breast Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor which provides a better odds ratio than mammographic parenchymal density.

Detailed Description

In a previous cross sectional study in a group of women without breast cancer and with varying degrees of parenchymal density patterns, a strong association was demonstrated between Transillumination Breast Spectroscopy (TIBS) and x-ray derived mammographic density. From this, we expect that TIBS should also provide a comparable odds ratio (4-6) as mammographic density for breast cancer risk shown in other independent epidemiological studies. It is possible that TIBS may provide complementary information and a higher odds ratio if compared to the incidence of breast cancer. In contrast to mammography derived parenchymal density pattern, no historical TIBS data is available for a retrospective analysis and hence a cross sectional study within a group of screened women is proposed. We hypothesize that TIBS provides physical information about the breast tissue which can be used to construct a breast cancer risk predictor with an odd ratio \> 6.

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Start: 2006-07
• Primary Completion: 2009-03
• Study Completion: 2009-09
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Are in good health and capable of providing consent
• Are willing to come in to the Princess Margaret Hospital for a single visit to meet with a female research assistant

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Exclusion Criteria

• Have had breast augmentation or reduction
• Have a personal history of breast cancer
• Have had a previous bilateral fine needle aspiration or core biopsy
• Have a breast tattoo

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

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

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