Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density

Breast Cancer Clinical Trial

Official title:

Optical Quantification of Breast Density Changes Due to Hormone Treatment, Pregnancy and Breast-feeding.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188760
• Other study ID #: UHNREB#02-0712-C
• Secondary ID: SGKBCF#BCTR04025
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: October 6, 2011
• Start date: May 2004
• Est. completion date: September 2010

Study information

• Verified date: October 2011
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test the ability of a technique called Transillumination Breast Spectroscopy (TIBS) to monitor an individual's breast density changes over time.

Description:

Breast density is an established physical risk factor for breast cancer, applicable to the entire female population in a pre-breast-screening program and, unlike other risk factors, was shown to be affected by an intervention treatment. High breast tissue density is associated with increased risk of breast cancer. Transillumination Breast Spectroscopy (TIBS) uses a white light to provide spectral information on breast tissue density and composition (e.g. water, lipid, hemoglobin and other biomolecules). The overall goal of the TIBS program is to develop a technique that can identify individuals at high risk for breast cancer who would benefit most from improved screening methods and a risk reducing intervention (e.g. diet and lifestyle changes) and can monitor the efficacy of the risk reducing intervention itself in an individual. In a previous study, we demonstrated a high correlation between breast density assessed by TIBS and density identified by x-ray mammography. The current study is testing TIBS ability to monitor changes in an individual's breast density over time

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Be in good health and able to provide consent

• Be between 25 and 45 years of age

• Be pre-menopausal

• Are willing to come in to Princess Margaret Hospital (Toronto, Ontario, Canada) for up to 12 visits at intervals of about three months

Exclusion Criteria:

• Have had a full term pregnancy

• Have had breast biopsy

• Have had breast augmentation or reduction

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Canada	Ontario Cancer Institute, Princess Margaret Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Dr. Julia Knight (research collaborator), Susan G. Komen Breast Cancer Foundation

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