MRI-guided Holmium-166 Radioembolization
Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 1, 2022
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Radboud University Medical Center
Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nijmegen, Gelderland, Netherlands
Patients applied
Trial Officials
Frank Nijsen, PhD
Principal Investigator
Radboud University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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