MRI-guided Holmium-166 Radioembolization

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

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

Conditions
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Primary Liver Cancer, Non-Resectable Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: MRI-guided radioembolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of hepatocellular carcinoma BCLC stage B or C At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO) Patient has a life expectancy of 12 weeks or longer Patient has a WHO performance score of 0-2 Exclusion Criteria: Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed) Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment Serum bilirubin > 2.0 x the upper limit of normal ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal Leukocytes <4.0 * 109/L or platelet count <60 * 109/L Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. Pregnancy or breast feeding Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) Portal vein thrombosis of the main branch (more distal branches are allowed) Untreated, active hepatitis Body weight > 150 kg (because of maximum table load) Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted. Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI-guided radioembolization<br>Study patients will receive radioembolization with holmium microspheres in an MRI guided setting. | Procedure: MRI-guided radioembolization<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TARE, hepatocellular carcinoma, radioembolization