Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)
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).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)|
- Difference in rate of change between the high risk groups and the respective controls [ Time Frame: over the 4 year duration of the study ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500383
|Juravinski Cancer Center, Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada|
|Women's College Hospital|
|Toronto, Ontario, Canada, M5S 1B2|
|Principal Investigator:||Lothar Lilge, PhD||Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9|