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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05609448
Other study ID # EMERITUS-2
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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