MRI-guided Holmium-166 Radioembolization

Trial Title: MRI-guided Holmium-166 Radioembolization

NCT ID: NCT05609448

Condition: Primary Liver Cancer
Non-Resectable Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms

Conditions: Keywords:
hepatocellular carcinoma
radioembolization
TARE

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: MRI-guided radioembolization
Description: 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.
Arm group label: MRI-guided radioembolization

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: RadboudUMC

Address:
City: Nijmegen
Zip: 6500 HB
Country: Netherlands

Start date: May 23, 2023

Completion date: October 2025

Lead sponsor:
Agency: Radboud University Medical Center
Agency class: Other

Collaborator:
Agency: Terumo Medical Corporation
Agency class: Industry

Source: Radboud University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05609448