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临床试验/NCT07055048
NCT07055048尚未招募不适用

The Diagnostic Efficacy and Lesion Detection Advantages of 18F-FDG PET/Contrast-enhanced MRI in Malignant Liver Lesions

Shanghai East Hospital0 个研究点目标入组 60 人开始时间: 2025年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Metabolic parameters

研究概览

简要总结

Liver disease, a major global health burden, ranges from mild dysfunction to severe conditions like cirrhosis and hepatocellular carcinoma (HCC), the fifth most common cancer. Accurate diagnosis of liver lesions-distinguishing benign from malignant-is vital for treatment planning. Conventional imaging (ultrasound, CT, MRI) has limitations in sensitivity and detecting small metastases. PET/CT combines metabolic and anatomical data but struggles with small lesions and cirrhotic livers.

18F-FDG PET/MRI with contrast-enhanced MRI may improve diagnostic accuracy, but its clinical benefits remain uncertain. Further research is needed to evaluate its performance, impact on patient outcomes, and cost-effectiveness in liver disease management.

详细描述

Liver disease is a major global public health challenge, ranging from mild dysfunction to severe conditions like cirrhosis and liver cancer. The high morbidity and mortality of liver diseases impose a significant socioeconomic burden, especially in developing countries. Primary liver cancer, particularly hepatocellular carcinoma (HCC), ranks as the fifth most common cancer and the third leading cause of cancer-related deaths worldwide. Additionally, the liver is a frequent site for metastases, and their presence critically impacts patient prognosis and treatment strategies.

Accurate diagnosis of liver lesions is essential for improving patient outcomes. Distinguishing benign from malignant lesions helps avoid unnecessary invasive procedures and ensures timely treatment. Similarly, early detection of liver metastases is crucial for cancer management and survival.

Conventional imaging techniques-such as ultrasound, CT, and MRI-are widely used for liver lesion assessment but have limitations, including insufficient specificity/sensitivity and difficulty in detecting small metastases. PET/CT, combining metabolic and anatomical data, is valuable in oncology but has drawbacks in liver applications, such as limited resolution for small lesions and challenges in differentiating malignancies in cirrhotic livers. Radiation exposure from CT is another concern.

In contrast, 18F-FDG PET/MRI with contrast-enhanced abdominal MRI offers a promising alternative, potentially improving diagnostic accuracy. However, despite its theoretical advantages, the actual clinical benefits remain unclear. A comprehensive study is needed to evaluate its diagnostic performance, accuracy, and impact on patient outcomes. Such research would validate its clinical utility, guide optimized treatment strategies, and ensure cost-effective integration into liver disease management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years;
  • Patients with suspected liver metastases or hepatic lesions,
  • Ability to undergo 18F-FDG PET/MRI examination;
  • Willingness to comply with study protocols.

排除标准

  • Patients with a history of allergic reactions to MRI contrast agents;
  • Pregnant or lactating women;
  • Patients with severe comorbidities, including: Cardiac disease,Renal failure,or Hepatic failure (Child-Pugh C);
  • Patients unable to cooperate with PET/MRI procedures.

结局指标

主要结局

Metabolic parameters

时间窗: After the patient completes the scan, an average of 2 days.

For all liver lesions, the maximum standardized uptake value (SUVmax) will be calculated.

MRI enhancement pattern

时间窗: After the patient completes the scan, an average of 2 days.

The MRI protocol will specifically evaluate the dynamic contrast-enhanced patterns of lesions, including their enhancement characteristics during the arterial phase, portal venous phase, and delayed phase.

Normal liver SUVmax

时间窗: After the patient completes the scan, an average of 2 days.

Calculate the maximum standardized uptake value (SUVmax) of normal liver tissue surrounding the lesion.

次要结局

未报告次要终点

研究者

发起方
Shanghai East Hospital
申办方类型
Other
责任方
Sponsor

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