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3T MRI to Predict TACE Response of HCC

2014年2月23日 更新者:National Taiwan University Hospital

Combination of Dynamic Contrast-enhanced and Diffusion-weighted Imaging and Magnetic Resonance Spectroscopy in 3T MRI to Early Predict Treatment Efficacy in Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma

This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor responses. After day 28, all subjects will receive standard clinical care and be follow-up for 1 year. The imaging parameters will be compared among each MRI and correlate with patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI, DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.

研究概览

地位

未知

详细说明

Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is a non-invasive quantitative technique for assessing micro-vascular structure by tracking the pharmacokinetics of injected low-molecular weight contrast agents as they pass through the tumor vasculature. This modality is being increasingly used in many oncological studies to characterize tumor angiogenesis and invasiveness, and monitor the treatment response.

Diffusion-weighted imaging (DWI) enables qualitative and quantitative assessment of tissue diffusivity (apparent diffusion coefficient, ADC) without the use of gadolinium chelates. DWI has been suggested to be useful in monitoring the response of HCC after TACE because of earlier assessment of tumor necrosis with increasing ADC values.

MR spectroscopy facilitates the study of cellular metabolism and in vivo detection of abnormalities. A few studies of in vivo MR spectroscopy reported an increase in choline levels within tumors such as HCC and a reduction in the lipid-to-choline ratio after conventional TACE was performed for HCC.

研究类型

观察性的

注册 (预期的)

100

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

      • Taipei、台湾、100
        • 招聘中
        • National Taiwan Uinversity Hospital
        • 接触:
        • 首席研究员:
          • Bang-Bin Chen, MD

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

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Hospital patients, admitted for TACE treatment of HCC

描述

Inclusion Criteria:

  1. Prior Informed Consent Form
  2. Patients who had undergone surgery for the treatment of HCC are allowed.
  3. At least one measurable tumor, according to RECIST version 1.1.
  4. Age more than 20 years.
  5. ECOG performance status 0 or 1.
  6. Life expectancy more than 3 months.
  7. Child-Pugh class A.
  8. Unresectable, multinodular tumors
  9. Confirmed Diagnosis of HCC
  10. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by MRI
  11. Adequate bone marrow, liver and renal function

Exclusion Criteria:

  1. History of TACE
  2. Diffuse infiltrative HCC or presence of main portal vein invasion or extrahepatic metastasis
  3. Any contraindications for hepatic embolization procedures:, including hepatofugal blood flow, large intrahepatic or porto-systemic shunt, impaired clotting test, renal failure requiring hemo-or peritoneal dialysis
  4. Any contraindication for MRI, including known contrast allergy, electronically operated implants or devices, and claustrophobia.
  5. Other acute or chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and is inappropriate for this study by the judgment of the investigator
  6. Known history of HIV infection
  7. Concurrent primary extrahepatic cancer
  8. Pregnant or breast-feeding subjects

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
TACE patients, for HCC
unresectable HCC patients

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
tumor response
大体时间:change of tumor size from baseline to at 6 months
change of tumor size from baseline to at 6 months
change of tumor size from baseline to at 6 months

次要结果测量

结果测量
措施说明
大体时间
change of baseline MRI parameters
大体时间:change of MRI parameters from baseline to at 6 months
comparsion of MRI parameters from baseline to 6 months
change of MRI parameters from baseline to at 6 months

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:Bang-Bin Chen, MD、National Taiwan Uinversity 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

2011年8月1日

初级完成 (预期的)

2014年12月1日

研究完成 (预期的)

2014年12月1日

研究注册日期

首次提交

2012年1月2日

首先提交符合 QC 标准的

2014年2月23日

首次发布 (估计)

2014年2月25日

研究记录更新

最后更新发布 (估计)

2014年2月25日

上次提交的符合 QC 标准的更新

2014年2月23日

最后验证

2014年2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.

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