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.

University Health Network, Toronto

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00188721

HC#96142

UHNREB#03-0462-CE

Details and patient eligibility

About

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 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

1

Description:

Women with confirmed unilateral breast carcinoma or ductal carcinoma in situ (DCIS)

2

Description:

Women without radiological suspicious lesions, matched to cases by age (± 2.5 years), date of screening mammogram, and screening center.