Clinical trial · Interventional
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
NCT05743842CI-TRIAL-00105039active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
To learn if using the TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Angiogram | Diagnostic Test | — | UNRESOLVED |
| TriSalus™ TriNav™Infusion System | Device | — | UNRESOLVED |
| Y90-radioembolization procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TriSalus™ TriNav™Infusion System (catheter)
- description
- TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter
- interventionNames
- Device: TriSalus™ TriNav™Infusion System
- Diagnostic Test: Angiogram
- Procedure: Y90-radioembolization procedure
Primary outcomes (1)
- measure
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
- timeFrame
- Through study completion; an average of 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent. * Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. * At least one lesion ≥ 3.0 cm in shortest dimension * Negative pregnancy test in premenopausal women Exclusion Criteria: * Contraindications to angiography and selective visceral catheterization * Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection. * Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels) * Infiltrative tumors * Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm
References
Publications (0)
Data not yet available
No reference posted for this study.