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Not Yet Recruiting NCT05609448

MRI-guided Holmium-166 Radioembolization

Conditions: Primary Liver Cancer, Non-Resectable Hepatocellular Carcinoma

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 15
Sponsor: Radboud University Medical Center

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:Diagnosis of hepatocellular carcinoma BCLC stage B or CAt least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CTPatient is eligible for TARE as determined by the tumour board (in Dutch: MDO)Patient has a life expectancy of 12 weeks or longerPatient has a WHO performance score of 0-2Exclusion 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 treatmentSerum bilirubin > 2.0 x the upper limit of normalALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normalLeukocytes <4.0 * 109/L or platelet count <60 * 109/LSignificant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.Pregnancy or breast feedingDisease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosumPatients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)Portal vein thrombosis of the main branch (more distal branches are allowed)Untreated, active hepatitisBody 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05609448). StuddyBuddy aggregates publicly available trial information.