Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT01773551 |
Other study ID # |
20128714 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 2012 |
Est. completion date |
April 2018 |
Study information
Verified date |
October 2022 |
Source |
University of California, Irvine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.