NCT00540306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

6.7 years

First QC Date

October 4, 2007

Last Update Submit

October 19, 2022

Conditions

Accessory; Breast Tissue

Keywords

breast tissue

Outcome Measures

Primary Outcomes (1)

  • Breast Tissue Physiology

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

    4 weeks

Study Arms (1)

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

Interventions

Diffuse Optical SpectroscopyDEVICE

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

Also known as: Diffuse Optical Spectroscopy Imaging
Diagnostic Tool

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic, community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute University of California Irvine

Irvine, California, 92612, United States

Location

Study Officials

  • Bruce J Tromberg, Ph.D

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bruce Tromberg,Ph.D.,Director, Beckman Laser Institute and Medical Clinic and Professor, Departments of Biomedical Engineering and Surgery

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

February 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)