MRI-guided Holmium-166 Radioembolization

Not Applicable

• Conditions: Non-Resectable Hepatocellular Carcinoma; Primary Liver Cancer
• Interventions: Procedure: MRI-guided radioembolization

• Registration Number: NCT05609448
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-08
• Study Start: 2023-05-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-01
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI-guided radioembolization	MRI-guided radioembolization	Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.

Primary Outcome Measures

Name	Time	Method
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.
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.
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 Outcome Measures

Name	Time	Method
Dosimetry optimization	12 months after treatment	Perform optimization of holmium dosimetry using SPECT and MRI

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Netherlands