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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai East Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Research group

Trial outcomes

Primary outcomes

1

Metabolic parameters

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

Time frame
After the patient completes the scan, an average of 2 days.
2

MRI enhancement pattern

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.

Time frame
After the patient completes the scan, an average of 2 days.
3

Normal liver SUVmax

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

Time frame
After the patient completes the scan, an average of 2 days.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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