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Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

25 Years
60 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

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

Inclusion Criteria:

BrCa carriers (cases)

- Attending one of the three participating high-risk screening centres

- Confirmed BrCa1 or BrCa2 mutation status through genetic testing

High-Risk (cases)

- Attending one of the three participating high-risk screening centres

- Confirmed negative BrCa1/2 status through genetic testing

BrCa non-carriers (controls)

- Attain a GAIL model score of <1.1 and have <10% risk of carrying the BRCa mutation
Determined by the Penn II model)

- Controls from high-risk screening centre with confirmed BrCa1/2 negative status
through genetic testing

- Preference will be given to sisters or first degree cousins of BrCa carriers

Exclusion Criteria:

Cases and Controls

- Prior diagnosis or Breast or Ovarian Cancer

- Bilateral biopsy or fine needle aspiration within 1 year of study start

- Bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)

- Previous or current chemotherapy or prevention therapy (Tamoxifen)

- Less than 3 years post pregnancy at study start

- inability to provide informed consent due to language or cognitive difficulties

*For controls only

- Family history of breast cancer where family member had an early diagnosis (before
age 45 years)

- Family history or ovarian cancer

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Lothar Lilge, PhD

Investigator Role:

Principal Investigator

Investigator 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


Canada: Health Canada

Study ID:




Start Date:

October 2009

Completion Date:

April 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer Risk
  • BRCA1
  • BRCA2
  • Breast Cancer Susceptibility gene
  • Optical Transillumination Spectroscopy
  • Transillumination Breast Spectroscopy
  • Breast Neoplasms