- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773551
Development of a Quantitative Tissue Optical Index of Breast Density For Prediction of Hormone Therapy Response
October 31, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine
Development of a Quantitative Tissue Optical Index of Breast Density
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.
Study Overview
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Costa Mesa, California, United States, 92627
- Pacific Breast Care Medical Clinic
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Irvine, California, United States, 92612
- Beckman Laser Institute Medical Clinic
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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San Francisco, California, United States, 94143
- Helen Diller Family Comprehensive Cancer Center/ UCSF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Two groups of subjects will be recruited:
- Pre-menopausal women who will receive the chemoprevention drug tamoxifen (treated)
- Pre-menopausal women who will not receive any chemoprevention drug (control)
Description
Treatment Group Inclusion Requirements
- Premenopausal or peri-menopausal female older than 21 years of age
- Elect to undergo, but have not yet started tamoxifen therapy;
- Not pregnant and willing to use adequate contraception for the duration of study participation; and
- 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
- Premenopausal or peri-menopausal female older than 21 years of age
- Not pregnant and willing to use adequate contraception for the duration of study participation;
Exclusion (both groups) Requirements
- Had or plan to receive any chemotherapy;
- Have bilateral breast cancer
- Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy;
- Are pregnant or nursing;
- Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants;
- Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities;
- Have received orthodontic work involving ferromagnetic materials;
- Are claustrophobic; or
- Medically unstable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Optical Index of Breast Density
Breast Density
|
Development of a Quantitative Tissue Optical Index of Breast Density
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast Density
Time Frame: up to 18 months
|
Breast Density
|
up to 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas O' Sullivan, PhD, Beckman Laser Institute, UCI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (ANTICIPATED)
April 1, 2018
Study Completion (ANTICIPATED)
April 1, 2018
Study Registration Dates
First Submitted
January 14, 2013
First Submitted That Met QC Criteria
January 18, 2013
First Posted (ESTIMATE)
January 23, 2013
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20128714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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