An observational study in Hepatic Malignant Tumors and Hepatic Perfusion Disorders, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Enrolling by invitation at 1 site in China. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
Hepatic malignant tumors are a category of diseases with high incidence and mortality rates worldwide, including various types such as primary hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and liver metastases. With the advancement of imaging technology, the number of hepatic perfusion disorders (HPD) detected in high-risk population screening and follow-up has gradually increased. However, the imaging manifestations of these HPD are highly heterogeneous, and the imaging features of some benign lesions (such as post-treatment inflammatory reactions, arterioportal shunts, hyperplastic nodules, focal fat deposition or fibrotic nodules) overlap with those of malignant lesions, posing a challenge to accurate diagnosis. Therefore, how to improve the ability to distinguish the benign and malignant nature of HPD based on multimodal imaging technology and optimize the follow-up management of high-risk populations has significant clinical value.
Hepatic malignant tumors, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and liver metastases, represent a significant global health burden due to their high incidence and mortality rates. With advancements in imaging techniques, the detection of hepatic perfusion disorders (HPD) in high-risk populations during screening and follow-up has increased. However, the imaging characteristics of HPD lack distinct heterogeneity, and certain benign lesions-such as post-treatment inflammatory reactions, arterioportal shunts, hyperplastic nodules, focal fat deposition, or fibrotic nodules-may exhibit overlapping imaging features with malignant lesions, posing a challenge for accurate diagnosis.
Contrast-enhanced magnetic resonance imaging (CE-MRI) is a key modality for evaluating hepatic nodules. However, it has limitations in differentiating non-typical enhancement patterns of lesions, such as metastases with minimal microvascular invasion, as well as non-specific nodules in cirrhotic backgrounds. Contrast-Enhanced Ultrasound (CEUS), with its unique ability to provide real-time dynamic assessment of tumor perfusion, is increasingly recognized as a valuable tool for hepatic lesion evaluation. Compared to CE-MRI, CEUS offers superior temporal resolution and lower costs, particularly in early post-treatment efficacy assessment, hemodynamic evaluation, and differentiation of residual viable tumor tissue from post-treatment changes. Moreover, ultrasound-MRI fusion imaging enhances the detection of small hepatic lesions, while CEUS quantitative analysis allows for the evaluation of tumor microvascular parameters to predict early malignant transformation. These advancements provide a more reliable approach for identifying malignant HPD using CEUS-based techniques.
This multicenter, prospective study aims to integrate ultrasound-MRI fusion imaging and CEUS quantitative analysis to improve the precise identification of early malignant lesions within nodular HPD detected on CE-MRI. Additionally, this study seeks to establish high-level evidence supporting the use of CEUS with ultrasound-MRI fusion for accurate localization and characterization of malignant lesions. Ultimately, the findings will contribute to the optimization of surveillance strategies for high-risk populations, including individuals at risk for hepatocellular carcinoma and other malignant tumors.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 280 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Patients with nodular hepatic perfusion disorders
Exclusion Criteria:
Perform contrast-enhanced ultrasound examination on the benign nodular hepatic perfusion disorders and analyze the images
Perform contrast-enhanced ultrasound examination on the hepatic malignant lesions and analyze the images
Accuracy
The diagnostic model correctly distinguish between hepatic malignant lesions and benign nodular hepatic perfusion disorders.
Time frame: 2 years
Correlation
Correlation between nodular HPD and hepatic malignant lesions
Time frame: 2 years
False negative rate
The probability of misdiagnosing malignant liver lesions as benign nodular HPD by CE-MRI
Time frame: 2 years
Plan to share: No — The data cannot be shared because of ethical restrictions regarding human participant data.
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Second Affiliated Hospital, School of Medicine, Zhejiang University