Non-Resectable Hepatocellular Carcinoma, Primary Liver Cancer
Conditions
Keywords
hepatocellular carcinoma, radioembolization, TARE
Brief summary
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
Interventions
PROCEDUREMRI-guided radioembolization
Catheter placement will be performed using fluoroscopy, after which patients are transferred to the MRI scanner, where holmium microspheres are administered based on MRI dosimetry. Thereby, patients get a personalized dose administration.
Sponsors
Terumo Medical Corporation
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of hepatocellular carcinoma BCLC stage B or C 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
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. Leukocytes \<4.0 \* 109/L or platelet count \<60 \* 109/L 6. Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. 7. Pregnancy or breast feeding 8. Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum 9. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) 10. Portal vein thrombosis of the main branch (more distal branches are allowed) 11. Untreated, active hepatitis 12. Body weight \> 150 kg (because of maximum table load) 13. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) 14. Lung shunt \> 30 Gy, as calculated using scout dose 166Ho SPECT/CT. 15. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted. 16. 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 | Description |
|---|---|---|
| Toxicity profile of dose administration cohorts | 12 months after treatment | Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation. |
| Safety of MRI-guided radioembolization procedure | 12 months after treatment | Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization. |
| Time constraints of performing intraprocedural MRI-based dosimetry | during treatment procedure | Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day. |
| Feasibility of performing intraprocedural treatment planning | during treatment procedure | The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry optimization | 12 months after treatment | Perform optimization of holmium dosimetry using SPECT and MRI |
Countries
Netherlands
Outcome results
None listed