Measurements of Breast Tissue Optical Properties

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of California, Irvine
Sponsor:
Collaborators:
University of California, San Diego
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540540
First received: October 4, 2007
Last updated: June 6, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Accessory; Breast Tissue
Device: Diffuse Optical Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurements of Breast Tissue Optical Properties

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Healthy Breast [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 653
Study Start Date: December 1995
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Diffuse Optical Spectroscopy
    Breast properties scanning
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Non-pregnant woman age 18 yrs and older.

Exclusion Criteria:

  • pregnant woman and younger than 18 yrs of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540540

Contacts
Contact: Jennifer Ehren, PhD 949-825-6039 jehren@uci.edu
Contact: Thomas O'Sullivan, PhD 949.824.8838 tosulliv@uci.edu

Locations
United States, California
Pacific Breast Care Medical Clinic Recruiting
Costa Mesa, California, United States, 92627
Contact: Jennifer Ehren, PhD    949-824-6039    ehren@uci.edu   
Contact: Thomas O'Sullivan, PhD    949.824.3383    tosulliv@uci.edu   
Sub-Investigator: Alice Police, M.D         
Sub-Investigator: Thomas O'Sullivan, Ph.D.         
Sub-Investigator: Montana Compton, R.N.         
Sub-Investigator: Anais Leproux, Ph.D.         
Sub-Investigator: Amanda Durkin, B.S.         
Sub-Investigator: Ylenia Santoro, Ph.D.         
Sub-Investigator: Jennifer Ehren, Ph.D.         
Sub-Investigator: Robert Carroll, M.D         
Sub-Investigator: Freddie Combs, M.D         
Sub-Investigator: Erin Lin, D.O.         
Beckman Laser Institute University of California Irvine Recruiting
Irvine, California, United States, 92612
Contact: Jennifer Ehren, PhD    949-824-6039    jehren@uci.edu   
Contact: Thomas O'Sullivan, PhD    949.824.8838    tosulliv@uci.edu   
Principal Investigator: Bruce J Tromberg, PhD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Anais Leproux, PhD         
Sub-Investigator: Thomas O'Sullivan, PhD         
Sub-Investigator: Jennifer Ehren, PhD         
Sub-Investigator: Ylenia Santoro, PhD         
UCSD Regional Fertility Center Recruiting
La Jolla San Diego, California, United States, 92037
Contact: Irene Su, M.D.    858-552-9177      
Contact: Jennifer Ehren, PhD    949.824.6039    jeheren@uci.edu   
Sub-Investigator: Irene Su, M.D.         
Sub-Investigator: Thomas O'Sullivan, Ph.D.         
Sub-Investigator: Jennifer Ehren, Ph.D.         
Chao Family Comprehensive Cancer Center, UCIMC Recruiting
Orange, California, United States, 92868
Contact: Jennifer Ehren, PhD    949-824-6039    jehren@uci.edu   
Contact: Thomas O'Sullivan, PhD    949.824.8838    tosulliv@uci.edu   
Sub-Investigator: David Hsiang, MD         
Sub-Investigator: John Butler, MD         
Sub-Investigator: Karen Lane, RN         
Sub-Investigator: Rita Mehta, MD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Anais Leproux, PhD         
Sub-Investigator: Thomas O'Sullivan, PhD         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Jennifer Ehren, PhD         
Sub-Investigator: Ylenia Santoro, PhD         
Sponsors and Collaborators
University of California, Irvine
University of California, San Diego
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Bruce J Tromberg, Ph.D Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Bruce Tromberg, PhD, Director Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540540     History of Changes
Other Study ID Numbers: NIH/LAMMP-1995-563
Study First Received: October 4, 2007
Last Updated: June 6, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 02, 2015