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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188721
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 12, 2011
Information provided by:
University Health Network, Toronto

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.

Condition or disease
Breast Cancer

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.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Transillumination for Breast Cancer Risk Assessment
Study Start Date : July 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188721

Canada, Ontario
Ontario Cancer Institute, Princess Maraget Hospital
Toronto, Ontario, Canada, M5G 2M9
Ontario Cancer Institute, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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