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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of California, Irvine
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01773551
First received: January 14, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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 Intervention
Accessory; Breast Tissue
Other: Breast Density

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development of a Quantitative Tissue Optical Index of Breast Density

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

Primary Outcome Measures:
  • Breast Density [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
    Breast Density


Estimated Enrollment: 36
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Optical Index of Breast Density
Breast Density
Other: Breast Density
Development of a Quantitative Tissue Optical Index of 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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773551

Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu
Contact: Jennifer Ehren, PhD 949-824-9265 jehren@uci.edu

Locations
United States, California
Pacific Breast Care Medical Clinic Recruiting
Costa Mesa, California, United States, 92627
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Sub-Investigator: Alice Police, MD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Anais Leproux, PhD         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Ylenia Santoro, PhD         
Sub-Investigator: Jennifer Ehren, PhD         
Sub-Investigator: Freddie Combs, MD         
Principal Investigator: Thomas O'Sullivan, PhD         
Beckman Laser Institute Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Principal Investigator: Thomas O' Sullivan, PhD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Anais Leproux, Ph.D.         
Sub-Investigator: Ylenia Santoro, PhD         
Sub-Investigator: Jennifer Ehren, PhD         
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Sub-Investigator: John Butler, MD         
Sub-Investigator: David Hsiang, MD         
Sub-Investigator: Rita Mehta, MD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Anais Leproux, PhD         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Ylenia Santoro, PhD         
Principal Investigator: Thomas O'Sullivan, PhD         
Sub-Investigator: Jennifer Ehren, PhD         
Helen Diller Family Comprehensive Cancer Center/ UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Dorota Wisner, MD, PhD    415-353-4313      
Sub-Investigator: Nola Hylton, PhD         
Sub-Investigator: Krysta Banfield         
Sub-Investigator: Roxana Dhada         
Sponsors and Collaborators
Montana Compton
University of California, San Francisco
Investigators
Principal Investigator: Thomas O' Sullivan, PhD Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: Montana Compton, Research Nurse, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01773551     History of Changes
Other Study ID Numbers: DOD BC120040
Study First Received: January 14, 2013
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014