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

NCT ID: NCT00540306

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2012-10-31

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.

Conditions

Accessory; Breast Tissue

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Diagnostic Tool

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

Diffuse Optical Spectroscopy

Intervention Type: DEVICE

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

Interventions

Diffuse Optical Spectroscopy

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

Intervention Type: DEVICE

Other Intervention Names

Diffuse Optical Spectroscopy Imaging

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce J Tromberg, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

Beckman Laser Institute University of California Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

20054760

Identifier Type: -

Identifier Source: org_study_id