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.
Full Title of Study: “Transillumination for Breast Cancer Risk Assessment”
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: March 2009
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.
Arms, Groups and Cohorts
- Women with confirmed unilateral breast carcinoma or ductal carcinoma in situ (DCIS)
- Women without radiological suspicious lesions, matched to cases by age (± 2.5 years), date of screening mammogram, and screening center.
Participating in This Clinical Trial
- 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 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
Gender Eligibility: Female
Minimum Age: 30 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University Health Network, Toronto
- Provider of Information About this Clinical Study
- Dr. Lothar Lilge, University Health Network
- Overall Official(s)
- Lothar Lilge, PhD, Principal Investigator, Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9
Blyschak K, Simick M, Jong R, Lilge L. Classification of breast tissue density by optical transillumination spectroscopy: optical and physiological effects governing predictive value. Med Phys. 2004 Jun;31(6):1398-414.
Simick MK, Jong R, Wilson B, Lilge L. Non-ionizing near-infrared radiation transillumination spectroscopy for breast tissue density and assessment of breast cancer risk. J Biomed Opt. 2004 Jul-Aug;9(4):794-803.
Blackmore KM, Knight JA, Jong R, Lilge L. Assessing breast tissue density by transillumination breast spectroscopy (TIBS): an intermediate indicator of cancer risk. Br J Radiol. 2007 Jul;80(955):545-56. Epub 2007 May 30.
Simick MK, Lilge L. Optical transillumination spectroscopy to quantify parenchymal tissue density: an indicator for breast cancer risk. Br J Radiol. 2005 Nov;78(935):1009-17.
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