检测前列腺癌的研究性扫描（基于 Dixon 序列的 MRI）
基于 Dixon 序列的 MRI 在前列腺癌检测中的评价
This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.
II. Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement.
SECONDARY OBJECTIVES:
I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.
II. Compare the accuracy of Dixon based sequences in detection of transition zone tumors.
III. Determine the optimal scanning parameters for Dixon based sequences in the imaging of prostate adenocarcinoma.
OUTLINE:
Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习地点
-
-
Texas
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Houston、Texas、美国、77030
- M D Anderson Cancer Center
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-
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:
- Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy.
- Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam.
- Patients who have signed their informed consent form to undergo the study.
Exclusion Criteria:
- Known prior hormone ablation or radiation therapy (pelvic or prostate).
- Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance.
- Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).
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：Diagnostic (standard MRI, Dixon MRI)
Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes. |
Undergo Dixon MRI
其他名称：
Undergo standard MRI
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Detection of at least one or more prostate lesions with Dixon sequencing
大体时间：through study completion, an average of 1 year
|
Will evaluate and compare the accuracy of Dixon based sequencing to the conventional T2 weighted sequencing for detection of intraprostatic tumor and extraprostatic tumor extension. Lesions will be within any of six regions of the prostate: left apex, left mid, left base, right apex, right mid, and right base. The relative sensitivity and specificity of the two sequencing methods will be compared using an adjusted McNemar's test for clustered data where clusters consist of the matched pairs of within patient-zone observations. The primary analysis will also provide 95% confidence intervals for marginal sensitivity and specificity using a generalized linear mixed model. |
through study completion, an average of 1 year
|
合作者和调查者
调查人员
- 首席研究员：Ganeshan Dhakshina Moorthy、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.