Light Based Analysis of Developing Breast Tissue in Adolescent Girls: a Feasibility Study

Breast Cancer Clinical Trial

Official title:

Pilot Study to Investigate the Feasibility of Optical Spectroscopy to Quantify Bulk Breast Tissue Properties in Girls Age 10 - 14 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188591
• Other study ID #: UHNREB#05-0154-CE
• Secondary ID: HC#92740
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: November 21, 2008
• Start date: April 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

The proposed pilot study attempts to investigate the feasibility of Optical Spectroscopy (OS) as a method to quantify breast tissue composition and density in adolescent females. Our goals include: to assess whether adolescent girls can be instructed to assist with the OS measurement procedure and to determine the OS technique's ability to show breast tissue composition and density in adolescent breast tissue.

Description:

The period between menarche and the age of first full-term pregnancy has been identified as being most crucial for establishing an individual's future breast cancer risk. Epidemiological studies further suggest exposures, such as foods and toxins, during adolescence to have a significant impact on the likelihood of transformation in the developing breast resulting in cancer later in life. Adolescent diet affects mammary development directly and indirectly by influencing the micronutrients and the hormonal status of the adolescent. The goal of this study is to investigate the feasibility of Optical Spectroscopy (OS), a method based on differential light scattering and absorption in tissue, to quantify bulk breast tissue properties in adolescent females.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria (Girls):

• Are in good health and are able to provide assent

• Are between the ages of 10 and 14

• Are interested in participating in this study

• Are willing to come, accompanied by a parent, to the Princess Margaret Hospital

Inclusion Criteria (Parents):

• Are able to provide consent

• Are willing to accompany your daughter to the Princess Margaret Hospital for one visit of about 45 minutes

Exclusion Criteria (Girls):

• Have had previous surgeries to the chest area

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
Canada	University Health Network / Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

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