Actively Recruiting
Comparison of MRI, CT, 18F-FDGal PET/CT, and 18F-choline PET/CT for Detecting and Staging Hepatocellular Carcinoma
Led by University of Aarhus · Updated on 2024-12-20
50
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) is the most common primary liver tumor and ranks as the fourth leading cause of cancer death worldwide. In Denmark, HCC occurs at a rate of 5.2 per 100,000 people annually, with a poor median survival time of just 7.7 months. Many patients with HCC have liver cirrhosis, and diagnosis is often made non-invasively using CT or MRI scans. MRI may be more sensitive than CT, especially for detecting small lesions. Positron emission tomography (PET) using different tracers is being studied to improve detection and staging of HCC, with 18F-FDGal and 18F-choline showing promise. This study compares two PET tracers, 18F-FDGal and 18F-choline, in 50 patients already diagnosed with HCC. Participants will undergo two PET/CT scans, one with each tracer. Additionally, some CT scans will be replaced by contrast-enhanced MRI scans. A standard contrast-enhanced CT scan will also be performed as part of routine care. Images from these scans will be reviewed by specialists to evaluate the ability of each tracer and imaging method to detect liver tumors and spread. During the study, participants will have PET/CT and MRI or CT scans to assess tumor presence and spread. Researchers will measure the accuracy, sensitivity, and specificity of the two PET tracers over a three-year period. Safety and feasibility of the scans will also be monitored. The total involvement duration depends on follow-up and imaging schedules during the study period.
CONDITIONS
Official Title
A Head-to-head Comparison of MRI, CT, 18F-FDGal and 18F-choline in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hepatocellular carcinoma
- Age above 18 years
You will not qualify if you...
- The patient does not want to take part in the study
- The responsible investigator determines that the patient is not qualified for a PET scan
- History of moderate or intense hypersensitivity to a gadolinium-based contrast agent
- Renal insufficiency with estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2 body surface area
- Contraindications for MRI including claustrophobia
- Pregnant or nursing patients
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
M
Mona Kristiansen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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