Individualized Dosimetry for Holmium-166-radioembolization in Patients With Unresectable Hepatocellular Carcinoma

Exclusion Criteria

• •A potential subject who meets any of the following criteria will be excluded from participation in this study:
• •1. Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening).
• •2. Hepatic radiation therapy within the last 4 weeks before the start of study therapy.
• •3. Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with sorafenib are allowed.
• •4. Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
• •5. Serum bilirubin \>34.2 micromole/L (2 mg/dL).
• •6. Glomerular filtration rate \<35 ml/min.
• •7. Non-correctable INR \>1.5 in case of femoral approach (as opposed to radial).
• •8. Leukocytes \<2 109/l and/or platelet count \<50 109/l.
• •9. Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2) within 3 months before entry, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia.
• •10. Pregnancy or breastfeeding.
• •11. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
• •12. Patients who are declared incapacitated.
• •13. Previous enrollment in the present study.
• •14. Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form), to prevent pregnancy in a partner.
• •15. Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta-blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
• •16. Portal vein thrombosis (tumor and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
• •17. Untreated active hepatitis. In case of detectable viral HBV load, appropriate treatment should be instituted.
• •18. Transjugular intrahepatic portosystemic shunt (TIPS).
• •19. Body weight over 150 kg (because of maximum table load).
• •20. Severe allergy for intravenous contrast used (Visipaque®)(because of CT evaluation, pre-treatment angiography and treatment angiography).
• •21. Lung shunt \>30 Gy, as calculated using scout dose SPECT/CT. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.