Status:
COMPLETED
Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Terumo Medical Corporation
Conditions:
Liver Cancer
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that ...
Eligibility Criteria
Inclusion
- Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer.
- At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT
- Patient is eligible for SIRT 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
- Significant extrahepatic disease (2x sum of diameters of lesions outside the liver \> sum of lesions inside the liver)
- 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
- Glomerular filtration rate (GFR-MDRD) \<35 ml/min
- 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)
- Evidence of clinically relevant, untreated grade 3 portal hypertension
- 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 holmium-166 SPECT/CT
- Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05183776
Start Date
July 12 2022
End Date
August 8 2023
Last Update
November 18 2023
Active Locations (1)
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1
RadboudUMC
Nijmegen, Netherlands