Clinical trial NCT00540540: Measurements of Breast Tissue Optical Properties
Official title: Measurements of Breast Tissue Optical Properties
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Accessory; Breast Tissue
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from University of California Irvine Medical Clinic and Cancer Center.

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.

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 criteria: Inclusion Criteria:

* Non-pregnant woman age 18 yrs and older.

Exclusion Criteria:

* pregnant woman and younger than 18 yrs of age.

Primary outcomes:
measure: Healthy Breast
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Pacific Breast Care Medical Clinic
state: California
city: Irvine
country: United States
facility: Beckman Laser Institute University of California Irvine
state: California
city: La Jolla San Diego
country: United States
facility: UCSD Regional Fertility Center
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, UCIMC
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Bruce J Tromberg, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: