Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers. These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

Sex

Female

Minimum age

25 Years

Maximum age

60 Years

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

• BACKGROUNDBlyschak 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. PMID 15259643
• BACKGROUNDSimick 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. PMID 15250768
• BACKGROUNDBlackmore 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. PMID 17537757
• BACKGROUNDSimick 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. PMID 16249602