MRI-guided Holmium-166 Radioembolization (EMERITUS-2)

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

To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Liver Cancer; Non-Resectable Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: MRI-guided radioembolization

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI-guided radioembolization; Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety of MRI-guided radioembolization procedure	Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.	12 months after treatment
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetry optimization	Perform optimization of holmium dosimetry using SPECT and MRI	12 months after treatment

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Terumo Medical Corporation
• Investigators: Principal Investigator: Frank Nijsen, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; radioembolization; TARE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: EMERITUS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data is available to other researchers upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No