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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188591
First Posted: September 16, 2005
Last Update Posted: November 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pilot Study to Investigate the Feasibility of Optical Spectroscopy to Quantify Bulk Breast Tissue Properties in Girls Age 10 - 14 Years

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 20
Study Start Date: April 2005
Study Completion Date: November 2008
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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents of Toronto, Ontario, Canada.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188591


Locations
Canada, Ontario
University Health Network / Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Lothar Lilge, PhD Ontario Cancer Institute, University Health Network, Toronto, Ontario, Canada M5G 2M9; Department of Biophysics and Bioimaging, University of Toronto, Toronto, Ontario, Canada M5G 2M9