Hepatic Malignant TumorsNCT06816212
Correlation Between CEUS Identification of Nodular HPD on CE-MRI and Hepatic Malignant Lesions
An observational study of Hepatic Malignant Tumors and Hepatic Perfusion Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatic Malignant Tumors, Hepatic Perfusion Disorders
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with nodular hepatic perfusion disorders
Who may be able to join
- Prospective cohort patients voluntarily sign the informed consent form.
- Patients with a history of malignant tumors, CE-MRI indicated the presence of HPD in the liver.
- The shape of HPD is nodular.
- The diameter of HPD is greater than 10mm.
- The main large vessels in the liver are clearly displayed in the MRI.
Who cannot join
- Patients who unable to complete imaging examinations, such as severe cardiac insufficiency, severe renal insufficiency, hypersensitivity to contrast agents or adverse reactions to them, etc.
- Patients with the history of extensive liver resection or liver transplantation.
- Patients whose abdomen with abundant intestinal gas.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: Correlation Between CEUS Identification of Hepatic Nodular Perfusion Disorders on CE-MRI and Hepatic Malignant Lesions: a Prospective Multicenter Study
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.
Read the detailed description
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.
- Keywords
- Hepatic malignant tumors, US-MRI image fusion, Contrast-Enhanced Ultrasound, quantitative analyses, Hepatic perfusion disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign nodular hepatic perfusion disorders | Perform contrast-enhanced ultrasound examination on the benign nodular hepatic perfusion disorders and analyze the images | |
| Hepatic malignant lesions | Perform contrast-enhanced ultrasound examination on the hepatic malignant lesions and analyze the images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The diagnostic model correctly distinguish between hepatic malignant lesions and benign nodular hepatic perfusion disorders.
Measured: 2 years
Correlation
Correlation between nodular HPD and hepatic malignant lesions
Measured: 2 years
False negative rate
The probability of misdiagnosing malignant liver lesions as benign nodular HPD by CE-MRI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start10 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816212
- Sponsor's protocol ID
- 2025-0104
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data cannot be shared because of ethical restrictions regarding human participant data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between CEUS Identification of Hepatic Nodular Perfusion Disorders on CE-MRI and Hepatic Malignant Lesions: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06816212
- Acronym / sponsor ID
- 2025-0104
- Keywords
- Hepatic malignant tumors, US-MRI image fusion, Contrast-Enhanced Ultrasound, quantitative analyses, Hepatic perfusion disorders
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign nodular hepatic perfusion disorders | – | –Perform contrast-enhanced ultrasound examination on the benign nodular hepatic perfusion disorders and analyze the images |
| Hepatic malignant lesions | – | –Perform contrast-enhanced ultrasound examination on the hepatic malignant lesions and analyze the images |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with nodular hepatic perfusion disorders
Key inclusion criteria (5 listed)
- Prospective cohort patients voluntarily sign the informed consent form.
- Patients with a history of malignant tumors, CE-MRI indicated the presence of HPD in the liver.
- The shape of HPD is nodular.
- The diameter of HPD is greater than 10mm.
- The main large vessels in the liver are clearly displayed in the MRI.
Key exclusion criteria (3 listed)
- Patients who unable to complete imaging examinations, such as severe cardiac insufficiency, severe renal insufficiency, hypersensitivity to contrast agents or adverse reactions to them, etc.
- Patients with the history of extensive liver resection or liver transplantation.
- Patients whose abdomen with abundant intestinal gas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy
Time frame: 2 years
The diagnostic model correctly distinguish between hepatic malignant lesions and benign nodular hepatic perfusion disorders.
Correlation
Time frame: 2 years
Correlation between nodular HPD and hepatic malignant lesions
False negative rate
Time frame: 2 years
The probability of misdiagnosing malignant liver lesions as benign nodular HPD by CE-MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. The data cannot be shared because of ethical restrictions regarding human participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Malignant Tumors and Hepatic Perfusion Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.