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Search / Trial NCT05609448

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

Hepatocellular Carcinoma Radioembolization Tare

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.

Locations

Nijmegen, Gelderland, Netherlands

Patients applied

0 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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