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Clinical Trials/NCT00540306
NCT00540306
Completed
Not Applicable

Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy

University of California, Irvine1 site in 1 country13 target enrollmentFebruary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Accessory; Breast Tissue
Sponsor
University of California, Irvine
Enrollment
13
Locations
1
Primary Endpoint
Breast Tissue Physiology
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to do determine the changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue components are 2) how predictable and repeatable these variations are 3) the effects of endogenous hormones on breast tissue physiology.

Detailed Description

Variations in breast physiology due to hormonal fluctuations during the menstrual cycle can correlate to quantitative changes in Diffuse Optical Spectroscopy functional parameters such as hemoglobin, lipid and water concentration and tissue scattering. Diffuse Optical Spectroscopy imaging can show increase blood flow in breast tissue after ovulation with a concomitant increase in mitotic activity, changes in hemoglobin concentration and in tissue scattering. Increases in fibroglandular breast tissue after ovulation have also been observed. Diffuse Optical Spectroscopy imaging can determine after time of ovulation has been detected during the two months of self-monitoring.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
October 2012
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beckman Laser Institute and Medical Center

Bruce Tromberg,Ph.D.,Director, Beckman Laser Institute and Medical Clinic and Professor, Departments of Biomedical Engineering and Surgery

University of California, Irvine

Eligibility Criteria

Inclusion Criteria

  • Pre-Menopausal female 18 years of age or older with normal breast tissue
  • Undergoes regular menstrual cycle cycles that do not vary by more than 5 days

Exclusion Criteria

  • Peri-Menopausal and Post-Menopausal
  • Subjects taking oral contraceptives or any birth control medications in the past six months
  • Diagnosed with breast cancer or cancer survivor,a history of breast surgery
  • Subjects taking light sensitive drugs for photodynamic therapy

Outcomes

Primary Outcomes

Breast Tissue Physiology

Time Frame: 4 weeks

Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle

Study Sites (1)

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