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

NCT ID: NCT00188591

Last Updated: 2008-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Optical Transillumination Spectroscopy Breast Cancer Risk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* Have had previous surgeries to the chest area
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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University Health Network

Principal Investigators

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Lothar Lilge, PhD

Role: PRINCIPAL_INVESTIGATOR

Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9

Locations

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University Health Network / Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 15259643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15250768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17537757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16249602 (View on PubMed)

Other Identifiers

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HC#92740

Identifier Type: -

Identifier Source: secondary_id

UHNREB#05-0154-CE

Identifier Type: -

Identifier Source: org_study_id