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