Pharmacological Manipulation of Intrahepatic Arterial Blood Flow in HCC
2021年4月26日 更新者：University Health Network, Toronto
Hepatic Arterial Blood Flow Modulation in Patients With Hepatocellular Carcinoma: Influence of Intra-arterial Norepinephrine Assessed With CT Perfusion
Dr Rajan is investigating a new method to improve local treatment of liver cancer.
There is evidence that a drug, norepinephrine (NE), has the ability to shrink down normal liver blood vessels, but leave tumor vessels wide open.
In patients with primary liver cancer, NE will be injected directly in the artery that nourishes the liver and the tumor.
Real time blood flow will be measured using an advanced CT scanner to demonstrate the NE effect on blood vessels.
If Dr Rajan's hypothesis is confirmed, this drug has great potential to benefit patients during local delivery of chemotherapy in the liver artery, diverting it away from normal liver and towards the tumor, resulting in less complications and improved tumor kill.
研究概览
详细说明
This study aims to evaluate the blood flow modifications in liver following injection of norepinephrine in the hepatic artery.
These blood flow variations have never been dynamically evaluated before.
If indeed blood flow modulation in liver is favorable, the use of norepinephrine prior to localized chemotherapy has great potential to enhance treatment and diminish side effects.
Patients with hepatocellular carcinoma, a primary liver cancer, will be selected for this study.
Included patients will have a trans-arterial chemoembolization (TACE) procedure scheduled as treatment for their cancer.
During their procedure, they will be brought to an advanced CT-scanner.
CT perfusion imaging will be performed prior, and after the injection of the study drug in the liver artery.
Patient's treatment will then be completed.
Perfusion color maps will illustrate blood flow.
Perfusion values will be correlated to see how the drug modulates blood flow in tumor and in normal liver.
研究类型
介入性
注册 (实际的)
10
阶段
- 第四阶段
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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Ontario
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Toronto、Ontario、加拿大、M5G 2N2
- Toronto General Hospital
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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:
- Biopsy proven HCC< or confident diagnosis of HCC on multi-phasic CT or MRI
- Selection criteria for chemoembolization must be met, including adequate coagulation profile and serum creatinine, patent portal vein, no severe contrast allergy, cirrhosis Child A or B.
- 5 or less untreated nodular hepatic tumors within the lobe to undergo chemoembolization. Larger nodule must be equal or over 3 cm.
- Patient must be able to provide written, informed consent.
Exclusion Criteria:
- Symptoms or history of ischemic cardiac disease or arrhythmia
- Uncontrolled hypertension
- Pregnancy or desire to get pregnant
- Severe COPD, FEVS lower than 30%
- Prior documented hypersensitivity to norepinephrine
- Patients receiving MAO inhibitors, or anti-depressants of the triptyline or imipramine types
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：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 |
|---|---|
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实验性的：Norepinephrine intra-arteriel/hepatic
This is the only arm of this study.
These patients will receive 24 micrograms of norepinephrine in the hepatic artery with subsequent CT perfusion imaging to evaluate liver blood flow.
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Two dynamic CT perfusion acquisitions of the whole liver will be performed with a 320-detectors CT, prior and after to the norepinephrine injection.
A small dose (24 ug) of norepinephrine will be injected in the hepatic artery over 10 seconds.
The half-life of the drug is 90 seconds..
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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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Liver blood flow
大体时间：1 minute following injection
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Liver blood flow as measured with CT perfusion
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1 minute following injection
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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：Dheeraj Rajan, MD FRCPC、University Health Network/Mount Sinai Hospital
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
2016年1月1日
初级完成 (实际的)
2020年12月1日
研究完成 (实际的)
2020年12月1日
研究注册日期
首次提交
2015年6月11日
首先提交符合 QC 标准的
2015年6月11日
首次发布 (估计)
2015年6月15日
研究记录更新
最后更新发布 (实际的)
2021年4月28日
上次提交的符合 QC 标准的更新
2021年4月26日
最后验证
2021年4月1日
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.
肝细胞癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung） | 药物相关副作用和不良反应（MeSH术语） | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤（皮肤癌） | 非小细胞肺癌（MeSH术语：Carcinoma, Non-Small-Cell Lung）意大利
CT perfusion的临床试验
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Kessler FoundationRutgers University; National Center for Medical Rehabilitation Research (NCMRR)完全的
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Seoul National University Bundang HospitalGE Healthcare; National Research Foundation of Korea完全的
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Northwell HealthToshiba America Medical Systems, Inc.邀请报名
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University of EdinburghNHS Lothian招聘中
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University of Alabama at BirminghamSociety of Abdominal Radiology完全的