Measurements of Breast Tissue Optical Properties

NCT00540540 | Withdrawn

• 1 other identifier: 1995563
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Accessory; Breast Tissue

Outcome Measures

Primary Outcomes (1)

• Healthy Breast

  up to 4 weeks

Interventions

Diffuse Optical Spectroscopy DEVICE

Breast properties scanning

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Non-pregnant woman age 18 yrs and older.

You may not qualify if:

• pregnant woman and younger than 18 yrs of age.

Sponsors & Collaborators

• University of California, Irvine: lead
• University of California, San Diego: collaborator
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (4)

Pacific Breast Care Medical Clinic

Costa Mesa, California, 92627, United States

Location

Beckman Laser Institute University of California Irvine

Irvine, California, 92612, United States

Location

UCSD Regional Fertility Center

La Jolla San Diego, California, 92037, United States

Location

Chao Family Comprehensive Cancer Center, UCIMC

Orange, California, 92868, United States

Location

Study Officials

• Bruce J Tromberg, Ph.D

  Beckman Laser Institute

  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, PhD, Director Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: December 1, 1995
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (4)