End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.

NCT07791446 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-88560
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Metastases; Tumor

Keywords

Y-90; The TriNav Infusion Systems

Outcome Measures

Primary Outcomes (1)

• Tumor Absorbed Dose (Gy)

  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.

  Within 1 day following intervention

Secondary Outcomes (4)

• Tumor-to-Normal Liver Ratio (T/N Ratio)

  Within 1 day following intervention

• Objective Response Rate (ORR) by RECIST 1.1

  3 months and 6 months after radioembolization

• Disease Control Rate (DCR) by RECIST 1.1

  3 months and 6 months after radioembolization

• Tumor Response by mRECIST for enhancing tumors

  3 months and 6 months after radioembolization

Study Arms (1)

Single Group

EXPERIMENTAL

Participants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant.

Device: The TriNav Infusion Systems; Device: Standard End Hole Microcatheter

Interventions

The TriNav Infusion Systems DEVICE

The Y-90 dose to be delivered by the TriNav Infusion System will be determined and recorded by the Investigator or Sub-Investigator, calculated using partition-based dosimetry software (i.e. MIM SurePlan or Simplicit90y)

Single Group

Standard End Hole Microcatheter DEVICE

The comparator is a standard end hole microcatheter, defined as any commercially available microcatheter utilizing a single end hole without balloon occlusion or other tip modifications. The Y-90 dose delivered by the standard end hole microcatheter will be determined and recorded by the Investigator or Sub-Investigator and calculated using partition-based dosimetry software (e.g., MIM SurePlan or Simplicit90Y).

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of multiple liver metastases
• Prior multidisciplinary clinical decision for treatment with radioembolization
• years of age or older
• ECOG less than or equal to 2
• Life expectancy \> 3 months
• Ability to understand and the willingness to provide written informed consent.
• At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor
• Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria
• At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site.
• Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm.
• The vessel level for each planned delivery site is no further distal than the segmental level.

You may not qualify if:

• Pregnant
• Breast-feeding
• Lung shunt fraction \> 20% or calculated lung dose \> 30 Gy
• Prior hepatic transarterial embolization in the hepatic lobe to be treated

Sponsors & Collaborators

• Stanford University: lead
• TriSalus Life Sciences, Inc.: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Matthew Hung, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittney Worley

CONTACT

650-736-3688; bw718@stanford.edu

David Marcellus

CONTACT

dmarcel2@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization occurs at the Y-90 delivery site level within participants, not between participant groups.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (1)