Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05359939

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hepatocellular carcinoma
  • Age above 18 years
Not Eligible

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

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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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