Actively Recruiting
A Head-to-head Comparison of MRI, CT, 18F-FDGal and 18F-choline in Patients With Hepatocellular Carcinoma
Led by University of Aarhus · Updated on 2024-12-20
50
Participants Needed
1
Research Sites
N/A
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-related death worldwide. In Denmark, the incidence is 5.2 per 100,000 population per year, with a median survival time of only 7.7 months. Since most patients with HCC have liver cirrhosis, diagnosis can often be made without invasive procedures by using characteristic contrast patterns on CT or MRI scans. Although both CT and MRI are standard, MRI may be better at detecting small liver lesions. This research aims to compare the effectiveness of two PET tracers, 18F-FDGal and 18F-choline, alongside MRI and CT to improve diagnosis and staging of HCC. In this study, fifty patients with known HCC will undergo two PET/CT scans using the tracers 18F-FDGal and 18F-choline. Some patients will also have a contrast-enhanced MRI scan instead of one of the CT scans, while a contrast-enhanced CT remains part of the standard diagnostic process. The images from these scans will be carefully analyzed and compared by specialists to assess the diagnostic performance of each tracer and imaging method. This head-to-head comparison intends to establish which tracer and imaging technique provide the best detection of both intra- and extrahepatic HCC. Participants will be involved in undergoing these imaging procedures, including PET/CT scans and possibly MRI. Specialists will monitor and interpret the imaging results for focal lesions. The primary outcome measured is the sensitivity and specificity of the two PET tracers over a three-year period, with secondary outcomes assessing MRI and CT effectiveness. The study is sponsored by the University of Aarhus and is planned to continue until December 2025, ensuring thorough evaluation of imaging methods in HCC diagnosis and staging.
CONDITIONS
Brief 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...
- Patient does not want to take part in the study
- Investigator determines patient is not qualified for a PET scan
- History of moderate or intense hypersensitivity to gadolinium-based contrast agent
- Renal insufficiency with estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2
- Contraindications for MRI including claustrophobia
- Pregnant or nursing patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo diagnostic scans including two PET/CT scans with 18F-FDGal and 18F-choline, a contrast-enhanced CT scan, and optionally a contrast-enhanced MRI scan as part of the standard diagnostic work-up.
1 to 3 visits depending on imaging procedures
Duration - Three years
Participants are monitored for up to three years to assess the sensitivity and specificity of the diagnostic imaging methods.
Follow-up visits as scheduled by the study team
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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