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

NCT07055048 | Not Yet Recruiting DMC

• 1 other identifier: 2024YS-212
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Cancer, Adult

Keywords

PET/MR; liver cancer

Outcome Measures

Primary Outcomes (3)

• Metabolic parameters

  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

  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

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jie Ding, MD

CONTACT

086-38804518; dingjie940406@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 8, 2025
• Study Start: June 30, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share