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Development of a Quantitative Tissue Optical Index of Breast Density For Prediction of Hormone Therapy Response

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ClinicalTrials.gov Identifier: NCT01773551
Recruitment Status : Withdrawn (Not NIH defined clinical trial study)
First Posted : January 23, 2013
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
University of California, San Francisco
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Brief Summary:
The purpose of this research study is to investigate whether breast density measured by a safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can detect the decrease of breast density in subjects who receive tamoxifen when compared to patients who do not receive any drug. If decreased density can be reliably detected, it may help determine which subjects will benefit by taking tamoxifen or other chemoprevention drugs.

Condition or disease Intervention/treatment
Accessory; Breast Tissue Other: Breast Density

Detailed Description:
The goal of this study is to develop a safe, painless imaging method to measure the change in breast density caused by hormonal chemotherapy treatments such as tamoxifen. For many patients with breast cancer, chemoprevention drugs (such as tamoxifen) can reduce the risk of recurrence. However, tamoxifen can also cause serious side effects such as blood clots and an increased risk of uterine cancer. Patients would benefit from an individualized method of determining whether the chemoprevention is working. Recent studies have shown that a course of tamoxifen is more effective at reducing risk in women who exhibit >10% reduction in breast density compared to women who had little or no density change. The study suggests that breast density is a predictor of the effectiveness of tamoxifen. We propose to use an imaging method that uses safe visible and near-infrared light to measure breast tissue called diffuse optical spectroscopic imaging. Diffuse optical spectroscopic imaging allows patients to be followed through treatment with a cost-effective, bedside, handheld scanning probe. In this study, we will examine whether diffuse optical spectroscopic imaging is sensitive to the density changes induced by tamoxifen as a preventative hormonal chemotherapy agent. MRI will be used as the standard for comparison. We expect to discover that after 12-18 months, women on tamoxifen treatment will show a significant reduction in breast density compared to women not taking tamoxifen, and this change can be monitored using DOSI alone. If validated, our method could be used to determine if tamoxifen treatment is working in an individual patient and could guide doctors about the decision to end and/or switch to a different treatment. In addition, a validated index of density that can be obtained using an inexpensive, risk-free bedside technology could be applied to the challenging problem of measuring individual risk of breast cancer in the broader population.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development of a Quantitative Tissue Optical Index of Breast Density
Study Start Date : April 2012
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Group/Cohort Intervention/treatment
Optical Index of Breast Density
Breast Density
Other: Breast Density
Development of a Quantitative Tissue Optical Index of Breast Density



Primary Outcome Measures :
  1. Breast Density [ Time Frame: up to 18 months ]
    Breast Density



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Two groups of subjects will be recruited:

  1. Pre-menopausal women who will receive the chemoprevention drug tamoxifen (treated)
  2. Pre-menopausal women who will not receive any chemoprevention drug (control)
Criteria

Treatment Group Inclusion Requirements

  1. Premenopausal or peri-menopausal female older than 21 years of age
  2. Elect to undergo, but have not yet started tamoxifen therapy;
  3. Not pregnant and willing to use adequate contraception for the duration of study participation; and
  4. Willing to avoid oral contraception use (which is not recommended while on tamoxifen treatment) for the duration of the study participation.

Normal Group Inclusion Requirements

  1. Premenopausal or peri-menopausal female older than 21 years of age
  2. Not pregnant and willing to use adequate contraception for the duration of study participation;

Exclusion (both groups) Requirements

  1. Had or plan to receive any chemotherapy;
  2. Have bilateral breast cancer
  3. Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy;
  4. Are pregnant or nursing;
  5. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants;
  6. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities;
  7. Have received orthodontic work involving ferromagnetic materials;
  8. Are claustrophobic; or
  9. Medically unstable.

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): NCT01773551


Locations
United States, California
Pacific Breast Care Medical Clinic
Costa Mesa, California, United States, 92627
Beckman Laser Institute Medical Clinic
Irvine, California, United States, 92612
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Helen Diller Family Comprehensive Cancer Center/ UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, Irvine
University of California, San Francisco
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Thomas O' Sullivan, PhD Beckman Laser Institute, UCI

Responsible Party: Beckman Laser Institute and Medical Center, Thomas O'Sullivan, Ph.D.Director, Diffuse Optical Spectroscopy & Imaging Laboratory, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01773551     History of Changes
Other Study ID Numbers: NIH/DOD-20128714
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018