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

Radboud University Medical Center

Status: Invitation-only

Conditions: Primary Liver Cancer; Non-Resectable Hepatocellular Carcinoma

Treatments: Procedure: MRI-guided radioembolization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05609448

EMERITUS-2

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MRI-guided radioembolization

Experimental group

Description:

Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.

Treatment:

Procedure: MRI-guided radioembolization