Clinical trial NCT05609448: MRI-guided Holmium-166 Radioembolization
Official title: Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Primary Liver Cancer
Non-Resectable Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
radioembolization
TARE
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Terumo Medical Corporation
First posted: 2022-11-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Toxicity profile of dose administration cohorts
timeFrame: 12 months after treatment
measure: Safety of MRI-guided radioembolization procedure
timeFrame: 12 months after treatment
measure: Time constraints of performing intraprocedural MRI-based dosimetry
timeFrame: during treatment procedure
measure: Feasibility of performing intraprocedural treatment planning
timeFrame: during treatment procedure
Secondary outcomes:
measure: Dosimetry optimization
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
Study officials:
affiliation: Radboud University Medical Center
name: Frank Nijsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: