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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07791446
Status
Not Yet Recruiting

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Conditions

  • Liver Metastases
  • Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)
  • 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).

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Tumor Absorbed Dose (Gy) [ Time Frame: Within 1 day following intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Brittney G Worley
[email protected]
650-736-3688
David G Marcellus, MD
[email protected]
Matthew Hung (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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