MRI-guided Holmium-166 Radioembolization (EMERITUS-2)
Primary Liver Cancer, Non-Resectable Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Primary Liver Cancer focused on measuring hepatocellular carcinoma, radioembolization, TARE
Eligibility Criteria
Inclusion Criteria: Diagnosis of hepatocellular carcinoma BCLC stage B or C At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO) Patient has a life expectancy of 12 weeks or longer Patient has a WHO performance score of 0-2 Exclusion Criteria: Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed) Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment Serum bilirubin > 2.0 x the upper limit of normal ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal Leukocytes <4.0 * 109/L or platelet count <60 * 109/L Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. Pregnancy or breast feeding Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) Portal vein thrombosis of the main branch (more distal branches are allowed) Untreated, active hepatitis Body weight > 150 kg (because of maximum table load) Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.
Sites / Locations
Arms of the Study
Arm 1
Experimental
MRI-guided radioembolization
Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.