Clinical trial · Interventional
End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
- 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)
Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System. A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.
Conditions
Conditions (2)
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 Metastases | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard End Hole Microcatheter | Device | — | UNRESOLVED |
| The TriNav Infusion Systems | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group
- description
- Participants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant.
- interventionNames
- Device: The TriNav Infusion Systems
- Device: Standard End Hole Microcatheter
Primary outcomes (1)
- measure
- Tumor Absorbed Dose (Gy)
- timeFrame
- Within 1 day following intervention
- description
- Tumor absorbed dose (Gy) measured using post-radioembolization \^90Y PET/CT and Simplicit90Y dosimetry analysis software. The endpoint will compare the absorbed dose delivered to tumors following Y-90 administration using the TriNav Infusion System versus a standard end-hole microcatheter.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Presence of multiple liver metastases 2. Prior multidisciplinary clinical decision for treatment with radioembolization 3. 18 years of age or older 4. ECOG less than or equal to 2 5. Life expectancy \> 3 months 6. Ability to understand and the willingness to provide written informed consent. 7. At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor 8. Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria 9. At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site. 10. Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm. 11. The vessel level for each planned delivery site is no further distal than the segmental level. Exclusion Criteria: 1. Pregnant 2. Breast-feeding 3. Lung shunt fraction \> 20% or calculated lung dose \> 30 Gy 4. Prior hepatic transarterial embolization in the hepatic lobe to be treated
References
Publications (0)
Data not yet available