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OpenTrials
Completed

NCT Number: NCT00188760

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

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.

Completed

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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Ontario Cancer Institute, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Dr. Julia Knight (research collaborator)
  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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