Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

Completed

Brief Summary: This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers. These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

Detailed Description: Preliminary data show Optical Breast Spectroscopy (OBS)has the ability to detect tissue differences with various pathologies and age-related changes in breast tissue over a two year period. In the present study, we want to determine whether OBS has the ability to detect optical differences between women who harbor a mutation in the breast cancer susceptibility gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). More specifically, possible differences in the breast tissue at time of enrollment into the study (reflecting changes potentially occurring in adolescence) and in the rate of breast tissue change over time (reflecting rate of tissue transformation from normal to ultimately malignant state). The overall goal is to develop a pre-screening technique to survey or monitor the risk of breast tissue and to advise the earliest point when imaging techniques (e.g. MRI) should be initiated or when more drastic primary prevention measures are recommended.

Recruitment & Eligibility

Inclusion Criteria

BrCa carriers (cases)

High-Risk (cases)

BrCa non-carriers (controls)

Attain a GAIL model score of <1.1 and have <10% risk of carrying the BRCa mutation Determined by the Penn II model)
Controls from high-risk screening centre with confirmed BrCa1/2 negative status through genetic testing
Preference will be given to sisters or first degree cousins of BrCa carriers

Exclusion Criteria

Cases and Controls

Prior diagnosis or Breast or Ovarian Cancer
Bilateral biopsy or fine needle aspiration within 1 year of study start
Bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
Previous or current chemotherapy or prevention therapy (Tamoxifen)
Less than 3 years post pregnancy at study start
inability to provide informed consent due to language or cognitive difficulties

*For controls only
Family history of breast cancer where family member had an early diagnosis (before age 45 years)
Family history or ovarian cancer

Primary Outcome Measures

Name	Time	Method
Difference in rate of change between the high risk groups and the respective controls	over the 4 year duration of the study	the primary optical measurements are utilized to determine principal component scores in the analysis which in turn will be used as time dependent variable in a linear regression analysis to determine the rate of change.

Secondary Outcome Measures

Name	Time	Method

Locations (4): Juravinski Cancer Center, Hamilton Health Sciences
🇨🇦
Hamilton, Ontario, Canada
Mount Sinai Hospital
🇨🇦
Toronto, Ontario, Canada
Women's College Hospital
🇨🇦
Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada

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