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

Completed

• Conditions: Accessory; Breast Tissue
• Interventions: Device: Diffuse Optical Spectroscopy

• Registration Number: NCT00540306
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-08
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic Tool	Diffuse Optical Spectroscopy	Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy

Primary Outcome Measures

Name	Time	Method
Breast Tissue Physiology	4 weeks	Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle

Trial Locations

Locations (1)

Beckman Laser Institute University of California Irvine; 🇺🇸 Irvine, California, United States