Clinical trial · Interventional
Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT
Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours
NCT05183776CI-TRIAL-00071512CONTROLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Primary Liver Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractional administration device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study patients
- description
- study patients will receive holmium radioembolization using a novel administration device.
- interventionNames
- Device: Fractional administration device
Primary outcomes (2)
- measure
- Validation of a fractional administration device for holmium radioembolization
- timeFrame
- 3 months after treatment
- description
- The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%.
- measure
- Safety of a fractional administration device for holmium radioembolization
- timeFrame
- 6 months after treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.