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

October 19, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92612
        • Beckman Laser Institute University of California Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

primary care clinic, community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic Tool
Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy
Device: Diffuse Optical Spectroscopy
Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy
Other Names:
  • Diffuse Optical Spectroscopy Imaging

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: Bruce J Tromberg, Ph.D, Beckman Laser Institute University of California Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20054760

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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