CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer
2022年6月30日 更新者：University of Washington
Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in Pancreatic Cancer
This pilot clinical trial studies how well computed tomography (CT) perfusion images work in assessing treatment response in patients with pancreatic cancer.
Analyzing specific measurements on the CT perfusion images may help doctors better determine how a tumor responds to chemotherapy and/or radiation therapy and may help guide treatment for patients with pancreatic cancer.
研究概览
详细说明
OUTLINE:
Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.
After completion of the study, patients are followed up periodically for 2 years.
研究类型
介入性
注册 (实际的)
70
阶段
- 不适用
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
-
-
Washington
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Seattle、Washington、美国、98109
- Fred Hutch/University of Washington Cancer Consortium
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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
18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
全部
描述
Inclusion Criteria:
- Signed informed consent form
- A diagnosis of pancreatic ductal adenocarcinoma
Exclusion Criteria:
- Patients unable to provide informed consent
- Women who are pregnant or intending to become pregnant during the study
- Patients with body mass index greater than 40 kg/m^2
- History of severe allergic-like reaction to iodinated contrast media
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
- 主要用途：其他
- 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 (CT perfusion sequence)
Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.
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Undergo CT perfusion sequence
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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 |
|---|---|---|
|
Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy
大体时间：Up to 4 years
|
Assessed using logistic regression.
Receiver operating characteristic (ROC) curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter.
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Up to 4 years
|
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Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment
大体时间：Up to 1 year
|
Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Assessed using logistic regression.
ROC curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter.
If multiple perfusion parameters are found to be predictive of response, a multivariate logistic regression model will be constructed with these variables.
ROC analysis will also be used to summary the predictive performance of the multivariate model.
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Up to 1 year
|
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Correlation of pre-treatment CT tumor perfusion parameters with overall survival
大体时间：At 1 year
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Assessed using Cox regression models.
Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
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At 1 year
|
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Correlation of pre-treatment CT tumor perfusion parameters with overall survival
大体时间：At 2 years
|
Assessed using Cox regression models.
Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
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At 2 years
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Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
大体时间：At 1 year
|
Assessed using Cox regression models.
Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
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At 1 year
|
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Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
大体时间：At 2 years
|
Assessed using Cox regression models.
Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
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At 2 years
|
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Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration)
大体时间：Baseline to post-treatment (up to approximately one year)
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The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated.
These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
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Baseline to post-treatment (up to approximately one year)
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Change in CT tumor perfusion parameter (blood flow)
大体时间：Baseline to post-treatment (up to approximately one year)
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The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated.
These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
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Baseline to post-treatment (up to approximately one year)
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Change in CT tumor perfusion parameter (blood volume)
大体时间：Baseline to post-treatment (up to approximately one year)
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The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated.
These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
|
Baseline to post-treatment (up to approximately one year)
|
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Change in CT tumor perfusion parameter (Ktrans)
大体时间：Baseline to post-treatment (up to approximately one year)
|
The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated.
These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test.
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Baseline to post-treatment (up to approximately one year)
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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。
调查人员
- 首席研究员：Ryan O'Malley、Fred Hutch/University of Washington Cancer Consortium
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 (实际的)
2017年6月22日
初级完成 (实际的)
2022年6月1日
研究完成 (实际的)
2022年6月1日
研究注册日期
首次提交
2017年1月3日
首先提交符合 QC 标准的
2017年1月5日
首次发布 (估计)
2017年1月6日
研究记录更新
最后更新发布 (实际的)
2022年7月6日
上次提交的符合 QC 标准的更新
2022年6月30日
最后验证
2022年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 9625 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
- NCI-2016-01780 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- RG3017007 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.