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

Accessory; Breast Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540306
• Other study ID #: 20054760
• Status: Completed
• Start date: February 2006
• Est. completion date: October 2012

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Accessory; Breast Tissue

Intervention

Device:
• Diffuse Optical Spectroscopy
Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy

Locations

Country	Name	City	State
United States	Beckman Laser Institute University of California Irvine	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast Tissue Physiology	Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle	4 weeks