分子乳腺成像 (MBI) 与乳腺磁共振成像 (MRI) 在识别和排除乳腺癌高危女性中的比较性能
To evaluate the diagnostic performance of Tc99m sestamibi (MBI) compared to breast MRI in women who are at high risk for developing breast cancer.
To assess the relationship of tumor size, histologic subtype and location of lesion and how it affects lesion conspicuity and sensitivity in MBI detected cancers.
研究概览
详细说明
Primary Objective:
-To compare the diagnostic performance of Molecular Breast Imaging (MBI) to breast Magnetic Resonance Imaging (MRI) in women who are at high risk of developing breast cancer.
Secondary Objectives:
- To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MBI compared to breast MRI in women who are at high risk of developing breast cancer.
- To assess patient preference for the two examinations by conducting a post examination survey and follow up questionnaire (see addendum).
- To assess the relationship of tumor size, histologic subtype and location of lesion with lesion conspicuity (mild, moderate, marked uptake compared to background activity) according to MBI lexicon [1].
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Beatriz Adrada
- 电话号码：(713) 792-2709
- 邮箱：beatriz.adrada@mdanderson.org
学习地点
-
-
Texas
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Houston、Texas、美国、77030
- 招聘中
- M D Anderson Cancer Center
-
首席研究员：
- Beatriz Adrada, MD
-
接触：
- Beatriz Adrada
- 电话号码：713-792-2709
- 邮箱：beatriz.adrada@mdanderson.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- The subjects to be studied will include female patients ages 18 and older of any race, identified as carrying an elevated risk for breast cancer referred to MDACC.
- High risk may be defined as having a calculated lifetime risk >20%, histopathology of lobular neoplasia or atypical ductal hyperplasia, atypia NOS or a genetic mutation known to predispose the patient to breast cancer.
- Subject who are scheduled for a Breast MRI who are willing to participate fully in all aspects of the study including completing both a Breast MRI & MBI screening exam within a two-week time window, a biopsy of any positive findings and complete a post examination survey. Consent for the enrollment may be obtained upon scheduling the MRI examination. For non-English speakers, a language interpreter will assist in translation.
- Written consent will be obtained from all participants to obtain MBI of the breasts and biopsy as indicated, based on findings. All participants will be asked to provide a post examination survey of their experience with both tests.
Exclusion Criteria:
- Subjects who are pregnant will be excluded as MBI exam involves injection of radioactive tracer
- contrast enhanced MRI involves gadolinium injection, both of which are contraindicated during pregnancy.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tc99m sestamibi
MBI uses an injection of a small amount of radioactive material called technetium99m (Tc99m) sestamibi |
Given by IV |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
确定分子乳腺成像 (MBI) 对乳腺磁共振成像 (MRI) 在患乳腺癌高风险女性中的诊断性能
大体时间：通过学习完成，平均1年
|
通过学习完成，平均1年
|
合作者和调查者
调查人员
- 首席研究员：Beatriz Adrada、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.