Viewing Study NCT00188760



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Study NCT ID: NCT00188760
Status: COMPLETED
Last Update Posted: 2011-10-07
First Post: 2005-09-09

Brief Title: Breast Study Investigating a New Light Technique to Monitor Changes in Breast Tissue Density
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Optical Quantification of Breast Density Changes Due to Hormone Treatment Pregnancy and Breast-feeding
Status: COMPLETED
Status Verified Date: 2011-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to test the ability of a technique called Transillumination Breast Spectroscopy TIBS to monitor an individuals breast density changes over time
Detailed Description: 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 eg 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 eg 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 individuals breast density over time

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
HC69745 None None None
SGKBCFBCTR0402530 None None None
MSHREB02-0226-E None None None
UTREB9313 None None None