Hepatocellular carcinoma Liver cancer
Conditions
Interventions
Ho-166-PLLA-MS will be administered using a medical device via a catheter
during MR imaging.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of hepatocellular carcinoma 2. At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT 3. Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO) 4. Patient has a life expectancy of 12 weeks or longer 5. Patient has a WHO performance score of 0-2
Exclusion criteria
Exclusion criteria: 1. Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed) 2. Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment 3. Serum bilirubin > 2.0 x the upper limit of normal 4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal 5. Glomerular filtration rate (GFR-MDRD) 150 kg (because of maximum table load) 15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) 16. Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT. 17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted. 18. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and feasibility of MRI guided administration of Ho-166-PLLA-MS in patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include response at 3, 6 and 12 months, and overall survival. | — |
Countries
Netherlands
Outcome results
None listed