Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

Breast Cancer Clinical Trial

Official title:

Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500383
• Other study ID #: UHNREB#07-0689-CE
• Secondary ID: HC#124313
• Status: Completed
• Phase: N/A
• First received: July 10, 2007
• Last updated: March 22, 2016
• Start date: October 2009
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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).

Description:

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 recommended.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Canada	Juravinski Cancer Center, Hamilton Health Sciences	Hamilton	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Hamilton Health Sciences Corporation, Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. Epub 2007 May 30. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in rate of change between the high risk groups and the respective controls	the primary optical measurements are utilized to determine principal component scores in the analysis which in turn will be used as time dependent variable in a linear regression analysis to determine the rate of change.	over the 4 year duration of the study	No

External Links

•   Transillumination Breast Spectroscopy Research Program