Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT

Inclusion criteria

• Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer.
• At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT
• Patient is eligible for SIRT 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

• Significant extrahepatic disease (2x sum of diameters of lesions outside the liver > sum of lesions inside the liver)
• 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
• Glomerular filtration rate (GFR-MDRD) <35 ml/min
• 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)
• Evidence of clinically relevant, untreated grade 3 portal hypertension
• 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 holmium-166 SPECT/CT
• Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.