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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Accessory; Breast Tissue

Intervention / Treatment
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* Device: Diffuse Optical Spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic Tool<br>Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy | Device: Diffuse Optical Spectroscopy<br>* Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy<br>* Other names: Diffuse Optical Spectroscopy Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Tissue Physiology | Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast tissue