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Measurements of Breast Tissue Optical Properties

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ClinicalTrials.gov Identifier: NCT00540540
Recruitment Status : Withdrawn (According to NIH definition of clinical trial studies, this study does not meet requirement for clinical trial study.)
First Posted : October 8, 2007
Last Update Posted : January 30, 2018
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

Brief Summary:
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 or disease Intervention/treatment
Accessory; Breast Tissue Device: Diffuse Optical Spectroscopy

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
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurements of Breast Tissue Optical Properties
Study Start Date : December 1995
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Intervention Details:
    Device: Diffuse Optical Spectroscopy
    Breast properties scanning

Primary Outcome Measures :
  1. Healthy Breast [ Time Frame: up to 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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.

Inclusion Criteria:

  • Non-pregnant woman age 18 yrs and older.

Exclusion Criteria:

  • pregnant woman and younger than 18 yrs of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540540

United States, California
Pacific Breast Care Medical Clinic
Costa Mesa, California, United States, 92627
Beckman Laser Institute University of California Irvine
Irvine, California, United States, 92612
UCSD Regional Fertility Center
La Jolla San Diego, California, United States, 92037
Chao Family Comprehensive Cancer Center, UCIMC
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
University of California, San Diego
Beckman Laser Institute University of California Irvine
Principal Investigator: Bruce J Tromberg, Ph.D Beckman Laser Institute

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
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018