Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer (MRSI+RRP)
2017年4月25日 更新者：Jackie Shannon、OHSU Knight Cancer Institute
Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer
A prostate cancer diagnosis starts a list of events that often leads to fast-moving treatment, thought by many to result in vast over-treatment of this disease.
So, discovery of different diagnostic methods that allow clinicians to identify slow-growing from potentially fast-growing disease prior to or at the time of prostate biopsy could result in early and suitable treatment for men at greatest risk, while greatly decreasing the number of biopsies, surgical procedures, hormonal and chemotherapeutic treatments, cost, and patient worry, for those with more slow-growing disease.
研究概览
研究类型
观察性的
注册 (实际的)
66
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Oregon
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Portland、Oregon、美国、97207
- Portland VA Medical Center
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Portland、Oregon、美国、97239
- Oregon Health & Science University Advanced Imaging Research Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
all men newly-diagnosed with prostate cancer at the Portland VA and OHSU Urology clinics
描述
Inclusion Criteria:
- Prostate cancer diagnosis prior to treatment
- Age 21 years or older
- Signed informed subject consent
- Prostatectomy as planned prostate cancer treatment
Exclusion Criteria:
- Men who do not choose prostatectomy
- Men who have undergone any neoadjuvant therapy
- Men who have cardiac pacemakers or other implanted electronic devices
- Men who have any surgically implanted metal
- Men who have had any surgical procedure that precludes placement of endorectal probe
- Indication of dementia or memory issues listed on problem list
- Men who indicate exposure to ocular metal fragments; confirmed by positive ocular x-ray
- Men who are taking newly-prescribed (within 6 months of enrollment) lipid control medications
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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High risk prostate cancer patients
Men who have been recently diagnosed with high risk prostate cancer (Gleason score 7 and above) and who choose prostate removal for their cancer treatment will undergo Magnetic Resonance Spectroscopy Imaging (MRSI) with rectal probe at the Oregon Health & Science University's Advanced Imaging Research Center.
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其他名称：
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Low risk prostate cancer patients
Men who have been recently diagnosed with low risk prostate cancer (Gleason score 7 [3+4] and below) and who choose prostate removal for their cancer treatment will undergo Magnetic Resonance Spectroscopy Imaging (MRSI) with rectal probe at the Oregon Health & Science University's Advanced Imaging Research Center.
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其他名称：
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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 |
|---|---|---|
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Number of participants with increased intraprostatic lipid concentration
大体时间：Up to 3 years
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Determine the correlation between the amount of intraprostatic lipid using 1H (proton) magnetic resonance spectroscopic imaging (MRSI) with an endorectal coil obtained prior to prostatectomy with fatty acid synthase protein expression measured in benign and cancer tissue from prostatectomy samples.
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Up to 3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with increased tumor aggressiveness
大体时间：Up to 3 years
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Identify the association between fatty acid synthase protein expression in prostatectomy samples, intraprostatic lipid as measured by 1H MRSI, and prostate tumor aggressiveness.
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Up to 3 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with accumulation of lipid intermediates and proteins
大体时间：Up to 3 years
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To quantify the association between key metabolic intermediates involved in lipid metabolism, mitochondrial function, inflammation, and apoptosis in prostatectomy samples and fatty acid synthase protein expression, intraprostatic lipid and tumor aggressiveness.
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Up to 3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Jonathan Q Purnell, MD、Oregon Health and Science University
- 首席研究员：Jackilen Shannon, PhD、Oregon Health and Science University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2017年3月1日
研究注册日期
首次提交
2013年1月7日
首先提交符合 QC 标准的
2013年1月29日
首次发布 (估计)
2013年1月31日
研究记录更新
最后更新发布 (实际的)
2017年4月27日
上次提交的符合 QC 标准的更新
2017年4月25日
最后验证
2016年11月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB00008458
- 2978 (其他标识符：Portland VA Medical Center IRB)
- W81XWH-12-1-0168 (其他赠款/资助编号：Dept of Defense)
- 8458 (其他标识符：Oregon Health & Science University IRB)
- Log #A-17208 (其他标识符：Dept of Defense Human Research Protection Office)
- PC110361 (其他标识符：Dept of Defense)
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.