Clinical trial · Interventional
MRI-guided Holmium-166 Radioembolization
Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study
NCT05609448CI-TRIAL-00071513EMERITUS-2unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Resectable Hepatocellular Carcinoma | — | UNRESOLVED | — |
| Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-guided radioembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-guided radioembolization
- description
- Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.
- interventionNames
- Procedure: MRI-guided radioembolization
Primary outcomes (4)
- measure
- Toxicity profile of dose administration cohorts
- timeFrame
- 12 months after treatment
- description
- Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.
- measure
- Safety of MRI-guided radioembolization procedure
- timeFrame
- 12 months after treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.