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临床试验/NCT01773551
NCT01773551
撤回
不适用

Development of a Quantitative Tissue Optical Index of Breast Density

University of California, Irvine4 个研究点 分布在 1 个国家2012年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Accessory; Breast Tissue
发起方
University of California, Irvine
试验地点
4
主要终点
Breast Density
状态
撤回
最后更新
3年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2012年4月
结束日期
2018年4月
最后更新
3年前
研究类型
Observational
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Beckman Laser Institute and Medical Center

Thomas O'Sullivan, Ph.D.Director, Diffuse Optical Spectroscopy & Imaging Laboratory

University of California, Irvine

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Breast Density

时间窗: up to 18 months

Breast Density

研究点 (4)

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