This study is planned to determine and compare two new radiotracers (11C-labeled metomidate and acetate) in the detection of malignant and benign hepatic tumors. The detection of hepatocellular carcinoma (HCC) is a challenging and difficult diagnostic problem by conventional methods, especially in cirrhotic patients(1).
Conditions
Interventions
Product Name: [11C]-Metomidate injection
Pharmaceutical Form:
Other descriptive name: [11C] Metomidate
Product Name: [11C]-Acetate
Pharmaceutical Form:
Other descriptive name: [11C] Acetate
Sponsors
Organisation name was not entered
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with incidentally detected liver masses (CT/MRI/US) or liver metastasis and known primary tumor who have not received oncologic treatment. • Patients must be in physical and psychological condition which allows them to participate to the study. • Patients must give written informed consent. • The histology of liver tumors will be confirmed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatments which might affect tracer binding to 11?-hydroxylase : ketoconazole and metyrapone as well as chemotherapy. • Vulnerable study subjects such as described in Finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included. Pregnancy will be excluded in all uncertain cases of fertile female with the Predictor pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The project aims at defining the potential of positron emissions tomography (PET) with the tracers 11C-metomidate and 11C-acetate for the differential diagnosis of lesions of the liver with the anatomic reference method of MRI using contrast enhanced agent (Dotarem®). Metomidate selectively binds to the enzyme 11?-hydroxylase which is specifically expressed in the adrenal cortex. Our aim is to study whether this tracer also accumulates to liver tumors and to show if this tracer can differentiate malignant (primary or metastatic) and benign liver tumors. ;Secondary Objective: ;Primary end point(s): The overall sample size of all participating PET services is 40, of which all will be studied at Turku PET Center. | — |
Countries
Finland
Outcome results
None listed