A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 9
- 主要终点
- Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as contrast-enhanced CT scan and contrast-enhanced MRI, may help find liver cancer and find out how far the disease has spread.
PURPOSE: This clinical trial is studying contrast-enhanced CT scan and contrast-enhanced MRI in diagnosing and staging liver cancer in patients with chronic liver disease.
详细描述
OBJECTIVES:
Primary
- To compare the sensitivity of multiphase contrast-enhanced CT scan to that of multiphase contrast-enhanced MRI using non-specific contrast agents for diagnosing hepatocellular carcinoma (HCC) in patients with chronic liver disease.
Secondary
- To compare the positive predictive value (PPV) of CT scan to that of MRI for diagnosing HCC.
- To compare the lesion-level sensitivity and PPV of CT scan and MRI as interpreted by radiologists at the respective transplant centers.
- To compare the sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC after local ablative therapy in patients listed for liver transplant.
- To determine the accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new Organ Procurement and Transplantation Network (OPTN) liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation.
- To explore whether the comparisons of sensitivity and PPV are affected by stratifying patients by AFP level (elevated vs normal). (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Waitlisted with HCC-Exception Points
Participants undergo CT and MRI every 90 days for the trial with iodinated contrast dye and motexafin gadolinium, during liver transplant wait listing. Possible Eovist-enhanced MRI substudy participation
干预措施: iodinated contrast dye (Drug)
Waitlisted with HCC-Exception Points
Participants undergo CT and MRI every 90 days for the trial with iodinated contrast dye and motexafin gadolinium, during liver transplant wait listing. Possible Eovist-enhanced MRI substudy participation
干预措施: motexafin gadolinium (Drug)
Waitlisted with HCC-Exception Points
Participants undergo CT and MRI every 90 days for the trial with iodinated contrast dye and motexafin gadolinium, during liver transplant wait listing. Possible Eovist-enhanced MRI substudy participation
干预措施: Eovist-enhanced MRI (Other)
结局指标
主要结局
Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)
时间窗: Within 90 Days Before Transplantation
次要结局
- Lesion-level sensitivity and PPV of contrast CT scan vs contrast MRI(Within 90 Days Before Transplantation)
- Accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new OPTN liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation(Within 90 Days Before Transplantation)
- Positive predictive value (PPV) of CT scan vs MRI for diagnosing HCC(Within 90 Days Before Transplantation)
- Sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC(Within 90 Days Before Transplantation)
- Diagnostic value of sensitivity and PPV when patients are stratified by AFP level (elevated vs normal)(Within 90 Days Before Transplantation)