Clinical trial NCT00188721: 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.
Official title: Transillumination for Breast Cancer Risk Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer Risk
Optical Transillumination Spectroscopy
Transillumination Breast Spectroscopy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cases and controls recruited from the Breast Imaging Clinic at Princess Margaret Hospital or the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto, Ontario, Canada)

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.

Eligibility criteria: 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ontario Cancer Institute, Princess Maraget Hospital
state: Ontario
city: Toronto
country: Canada
facility: Ontario Cancer Institute, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9
name: Lothar Lilge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1118/1.1738191.
citation: 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. doi: 10.1117/1.1758269.
citation: 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. doi: 10.1259/bjr/26858614. Epub 2007 May 30.
citation: 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. doi: 10.1259/bjr/14696165.