Clinical trial NCT00188591: Light Based Analysis of Developing Breast Tissue in Adolescent Girls: a Feasibility Study
Official title: Pilot Study to Investigate the Feasibility of Optical Spectroscopy to Quantify Bulk Breast Tissue Properties in Girls Age 10 - 14 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Optical Transillumination Spectroscopy
Breast Cancer Risk
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Toronto, Ontario, Canada.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network / Princess Margaret Hospital
state: Ontario
Study officials:
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
name: Lothar Lilge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1118/1.1738191.
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. doi: 10.1117/1.1758269.
citation: 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. doi: 10.1259/bjr/26858614. Epub 2007 May 30.
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. doi: 10.1259/bjr/14696165.