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

University of California Irvine (UCI)

Status: Completed

Conditions: Accessory; Breast Tissue

Treatments: Device: Diffuse Optical Spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT00540306

20054760

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Diagnostic Tool

Description:

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

Treatment:

Device: Diffuse Optical Spectroscopy