Clinical trial · Interventional
Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization
Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization for the Treatment of Colorectal Liver Metastases (SIM Trial)
NCT02208804CI-TRIAL-00024761SIMunknownPhase 2 / Phase 3ClinicalTrials.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)
The objective of the SIM trial is to investigate whether using the Surefire Infusion System during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity concentration ratio, compared with using a standard end-hole microcatheter.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Liver Diseases | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Holmium-166-poly (L-lactic acid) microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surefire Infusion System
- description
- Hepatic arterial administrations using the Surefire Infusion System
- interventionNames
- Device: Holmium-166-poly (L-lactic acid) microspheres
- type
- ACTIVE_COMPARATOR
- label
- Standard End-hole Microcatheter
- description
- Hepatic arterial administrations using the standard end-hole microcatheter
- interventionNames
- Device: Holmium-166-poly (L-lactic acid) microspheres
Primary outcomes (1)
- measure
- Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Histopathologically confirmed diagnosis of adenocarcinoma of the colon or rectum * Hepatic metastases with measurable morphological appearance (≥ 1 cm) on cross sectional imaging, located in the right and left hepatic arterial perfusion territory * Unresectable, liver dominant disease * Progressive disease after second line chemotherapy or no further chemotherapeutical treatment options due to severe side effects or unwillingness of the patient to undergo systemic chemotherapy * Age ≥ 18 years * Expected adequacy of follow-up Exclusion Criteria: * World health organization performance score \> 2 * Inadequate bone marrow function (hemoglobin \< 6.0 mmol/l, leukocyte count \< 3.0 x 109/l, platelet count \< 75x 109/l), inadequate liver function (bilirubin \> 35 µmol/l, aspartate aminotransferase / alanine aminotransferase (AST/ALT) \> 5 x upper limit of normal (ULN)) or inadequate renal function (creatinine \> 1.5 x ULN) * Prior hemihepatectomy * Compromised biliary system (biliary stent or hepaticojejunostomy) * Child Pugh score B7 or worse * Active hepatitis B or C * Main portal vein thrombosis on CT (or previous portal vein embolization) * Severe celiac axis stenosis on CT * Unsuitable hepatic arterial anatomy on CT * Treatment with systemic chemotherapy within 4 weeks prior to radioembolization * Previous participation in a study classified as class III by a radiation safety committee * Bleeding diathesis * Pregnancy or breast feeding * Life expectancy \< 3 months * Patients who are declared incompetent * Any condition that prevents from safe treatment with radioembolization
References
Publications (2)
- DERIVEDvan Roekel C, van den Hoven AF, Bastiaannet R, Bruijnen RCG, Braat AJAT, de Keizer B, Lam MGEH, Smits MLJ. Use of an anti-reflux catheter to improve tumor targeting for holmium-166 radioembolization-a prospective, within-patient randomized study. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1658-1668. doi: 10.1007/s00259-020-05079-0. Epub 2020 Oct 31. PMID 33128132
- DERIVEDvan den Hoven AF, Prince JF, Bruijnen RC, Verkooijen HM, Krijger GC, Lam MG, van den Bosch MA. Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial. Trials. 2016 Oct 25;17(1):520. doi: 10.1186/s13063-016-1643-3. PMID 27782851