Measurements of Breast Tissue Optical Properties

October 19, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Although the reason for this has not yet been demonstrated, this stability may be a direct consequence of early detection and improved therapy. Screening mammography as an early detection technique has been shown to reduce mortality by 23%. Mammographic abnormalities that go on to biopsy show 24% being positive for malignancy with great variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and surgery which may be obviated by more specific non-invasive testing.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Diffuse Optical Spectroscopic Imaging a new method for quantitative characterization of the optical properties of tissues. The diagnostic tools utilize anomalies in the transmission of diffusing near infra-red light for the rapid detection of oxygenated and deoxygenated hemoglobin, near infra-red absorbing drug levels, blood volume changes, and scattering properties in tissues.

Diffuse Optical Spectroscopic Imaging measurements of breast tissue optical properties probe is similar in shape to an ultrasound probe. The imaging can measurements on different areas of the breast including diseased location and normal area. Optical measurements can guided by co-registered ultrasound measurements for the purpose of determining lesion size and location. Each measurement will require about 5-60 seconds to record the data and calculate optical properties. The process will be repeated until an adequate number of measurements are performed and measurements take 30 to 90 minutes.

The researcher can determine that breast optical properties on demographic information, such as age and menopausal status as well as medical history.

Study Type

Observational

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
      • Costa Mesa, California, United States, 92627
        • Pacific Breast Care Medical Clinic
      • Irvine, California, United States, 92612
        • Beckman Laser Institute University of California Irvine
      • La Jolla San Diego, California, United States, 92037
        • UCSD Regional Fertility Center
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center, UCIMC

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Study population will be selected from University of California Irvine Medical Clinic and Cancer Center.

Description

Inclusion Criteria:

  • Non-pregnant woman age 18 yrs and older.

Exclusion Criteria:

  • pregnant woman and younger than 18 yrs of age.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healthy Breast
Time Frame: up to 4 weeks
up to 4 weeks

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Collaborators

University of California, San Diego
Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: Bruce J Tromberg, Ph.D, Beckman Laser Institute

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

December 1, 1995

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

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

Other Study ID Numbers

  • 1995563

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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