MRI-guided Holmium-166 Radioembolization

Primary Liver Cancer Clinical Trial

— EMERITUS-2  

Official title:

Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05609448
• Other study ID #: EMERITUS-2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: October 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms
• Non-Resectable Hepatocellular Carcinoma
• Primary Liver Cancer

Intervention

Procedure:
• MRI-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.

Locations

Country	Name	City	State
Netherlands	RadboudUMC	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Terumo Medical Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity profile of dose administration cohorts	Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.	12 months after treatment
Primary	Safety of MRI-guided radioembolization procedure	Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.	12 months after treatment
Primary	Time constraints of performing intraprocedural MRI-based dosimetry	Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.	during treatment procedure
Primary	Feasibility of performing intraprocedural treatment planning	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.	during treatment procedure
Secondary	Dosimetry optimization	Perform optimization of holmium dosimetry using SPECT and MRI	12 months after treatment