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Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy (DOS)

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Volighten Scientific, Ltd.
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540306
First received: October 4, 2007
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  Purpose

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call frequency-domain photon migration(FDPM) using Diffuse Optical Spectroscopy (DOS).

DOS methods are based on using intensity-modulated near-infrared light (NIR) to quantitatively measure intrinsic tissue absorption and scattering coefficients in vivo (UCI HS#1995-563). Optical properties can be used to spectroscopically quantify biological components in the tissue namely: deoxy-hemoglobin, oxy-hemoglobin, lipids, and water concentrations, which are related to tissue physiology and functioning. DOS techniques have shown success in characterizing tumor tissue and monitoring neoadjuvant chemotherapy(UCI HS#2002-2306).

Our objective in this study is to monitor the changes in the biochemical composition of the breast during the menstrual cycle of pre-menopausal women using DOS. Volume measurements will also be performed on each subject throughout the menstrual cycle to assess the amount of breast volume change. This study will allow us to accurately correlate DOS parameters to the dominant hormones present in the breast tissue at a given time as well as the physical changes in the breast that results from these hormone fluctuations.


Condition Intervention
Breast Disease
 Device: Diffuse Optical Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Menstrual Cycle Functional Variation in DOS

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • change of breast tissue physiology during menstrual cycle [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Diffuse Optical Spectroscopy
    breast laser scanning
Detailed Description:

After time of ovulation has been determined during the two months of self-monitoring the DOS measurements are performed using the laser breast scanner, which includes a hand-held probe with optical fibers same procedure of HS#1995-563 and HS#2002-2306. The hand-held probe is applied to the surface of the breast skin with no pressure, but only to ensure skin contact with the probe. Light is launched serially into tissue.

Subject will not feel pain or discomfort. DOS measurements will be taken on only the left breast. Fifteen points on the breast will be marked by using a non allergy surgical pen and markings will be removed after each measurement . Each individual DOS measurement takes about 20 seconds. Measurements will be repeated one time, amounting to a total of 30 measurements that will take approximately 30 minutes. The power of the light source is <20 mW, which is diffuse and comparable to halogen-bulb household flashlights. Following the DOS procedure measurements the breast will place into a 2-liter beaker filled with water. The volume of the breast is determined by measuring the volume of water displaced by the breast.

There are no direct diagnostic benefit can be expected from participation in this study. However, information obtained may lead to a new diagnostic technique to detect breast cancer that may prevent unnecessary surgery and may help improve breast cancer treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

  • Pre-Menopausal female 18 years of age or older with normal breast tissue
  • Undergoes regular menstrual cycle cycles that do not vary by more than 5 days

Exclusion Criteria:

  • Peri-Menopausal and Post-Menopausal
  • Subjects taking oral contraceptives or any birth control medications in the past six months
  • Diagnosed with breast cancer or cancer survivor,a history of breast surgery
  • Subjects taking light sensitive drugs for photodynamic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540306

Locations
United States, California
Beckman Laser Institute University of California Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Volighten Scientific, Ltd.
Investigators
Principal Investigator: Bruce J Tromberg, Ph.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540306     History of Changes
Other Study ID Numbers: LAMMP DOS-RR-01192-29.
Study First Received: October 4, 2007
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
breast tissue

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013