Liver Cancer, Liver Metastasis Colon Cancer, Primary Liver Cancer
Conditions
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 it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.
Interventions
DEVICEFractional administration device
The novel fractional administration device enable the administration of the microspheres in fractions determined by the user. For this study, 5 fractions of 20% will be administered and validated using MRI.
Sponsors
Terumo Medical Corporation
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer. 2. At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT 3. Patient is eligible for SIRT 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. Significant extrahepatic disease (2x sum of diameters of lesions outside the liver \> sum of lesions inside the liver) 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. Glomerular filtration rate (GFR-MDRD) \<35 ml/min 6. Leukocytes \<4.0 \* 109/L or platelet count \<60 \* 109/L 7. Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. 8. Pregnancy or breast feeding 9. Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum 10. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) 11. Portal vein thrombosis of the main branch (more distal branches are allowed) 12. Evidence of clinically relevant, untreated grade 3 portal hypertension 13. Untreated, active hepatitis 14. Body weight \> 150 kg (because of maximum table load) 15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) 16. Lung shunt \> 30 Gy, as calculated using scout dose holmium-166 SPECT/CT 17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of a fractional administration device for holmium radioembolization | 3 months after treatment | The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%. |
| Safety of a fractional administration device for holmium radioembolization | 6 months after treatment | The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accurate dosimetry based on MRI and SPECT imaging of holmium-166. | 6 months after treatment | To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response |
Countries
Netherlands
Outcome results
None listed