NCT05871892 18F-FDGal PET/CT and PET/MRI in Patients With Hepatocellular Carcinoma
| NCT ID | NCT05871892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2023-09-11 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hepatocellular carcinoma (HCC) is the most common primary liver tumor and the fourth leading cause of cancer-related death worldwide. In Denmark, the incidence of HCC is 5.2 per 100.000 population per year with a dismal prognosis as the median survival time is just 7.7 months. Extrahepatic spread of HCC is common at advanced stages with haematogenous spread to lungs, bones and adrenal glands or lymphatic spread to regional lymph nodes. The majority of patients who develop HCC have cirrhosis of the liver and in these patients, diagnosis can be made non-invasively with characteristic contrast-enhancement pattern on computed tomography (CT) and/or magnetic resonance imaging (MRI). Although contrast-enhanced CT and MRI are considered equal in current guidelines, MRI may have a better sensitivity especially for small lesions. Positron emission tomography (PET) is a molecular imaging technique based on the injection of a very small dose of a tracer substance labelled with a positron emitting radioisotope. PET with the glucose tracer 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) is an important tool in the staging of many cancer forms, but it is not included in the international guidelines for management of HCC because of suboptimal sensitivity of only up to 50-60 % for HCC situated in the liver. In Aarhus, the liver specific tracer 18F-FDGal has been developed. It is a fluorine-18 labelled galactose analogue which in the human body is trapped in hepatocytes by phosphorylation by galactokinase. The first study of the diagnostic use of 18F-FDGal PET/CT in patients suspected of having HCC was published in 2011. The study showed good clinical potential for 18F-FDGal as a tracer for detection of intra- as well as extrahepatic HCC. The aim of the present project is to establish the clinical impact and utilization of 18F-FDGal PET/CT and PET/MRI in patients suspected of having HCC or diagnosed with HCC, for staging and evaluation of treatment response including effect of treatment on liver function. Hypotheses: I. Adding 18F-FDGal PET/CT or PET/MRI to diagnostic work-up of patients suspected of or diagnosed with HCC will add to the establishment of a definitive diagnosis and improve staging and thus choice of treatment. II. The uptake pattern of 18F-FDGal in HCC provides prognostic information and can be used to evaluate regional metabolic liver function before and after loco-regional treatment.
Eligibility Criteria
Inclusion Criteria: * Newly-referred patients suspected of or diagnosed with HCC * Age above 18 years Exclusion Criteria: * 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. * Patients who are offered systemic chemotherapy or best supportive care will be excluded. * Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73 m2 body surface area). * Pregnant or nursing patients.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05871892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05871892 currently recruiting?
Yes, NCT05871892 is actively recruiting participants. Contact the research team at mkk@clin.au.dk for enrollment information.
Where is the NCT05871892 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT05871892 clinical trial?
NCT05871892 is sponsored by University of Aarhus. The trial plans to enroll 125 participants.
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