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

July 3, 2025 updated by: Shanghai East Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who meet the inclusion and exclusion criteria and are willing to follow the research process.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Research group
It is expected to include 60 patients with suspected hepatic space-occupying lesions , and the tracer radiation used in the study is extremely small and will not have any physiological effects on the subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic parameters
Time Frame: After the patient completes the scan, an average of 2 days.
For all liver lesions, the maximum standardized uptake value (SUVmax) will be calculated.
After the patient completes the scan, an average of 2 days.
MRI enhancement pattern
Time Frame: 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.
After the patient completes the scan, an average of 2 days.
Normal liver SUVmax
Time Frame: 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.
After the patient completes the scan, an average of 2 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 24, 2025

First Submitted That Met QC Criteria

July 3, 2025

First Posted (Estimated)

July 8, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024YS-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For the protection of patient privacy, we will not share patient information, but other researchers can apply through the project contact person if they have reasonable reasons.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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