Health TrialsbyHealthPanel

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

ConditionsLiver MetastasesTumor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of multiple liver metastases

Prior multidisciplinary clinical decision for treatment with radioembolization

18 years of age or older

ECOG less than or equal to 2

Disqualifiers

Pregnant

Breast-feeding

Lung shunt fraction > 20% or calculated lung dose > 30 Gy

Prior hepatic transarterial embolization in the hepatic lobe to be treated

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Single GroupExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Within 1 day following intervention

Secondary outcomes

1

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

T/N ratio measured on post-radioembolization \^90Y PET/CT using Simplicit90Y dosimetry analysis software. This endpoint evaluates preferential microsphere deposition within tumor relative to normal liver tissue and compares results between treatment groups.

Time frame
Within 1 day following intervention
2

Objective Response Rate (ORR) by RECIST 1.1

Proportion of target lesions achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.

Time frame
3 months and 6 months after radioembolization
3

Disease Control Rate (DCR) by RECIST 1.1

Proportion of target lesions achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.

Time frame
3 months and 6 months after radioembolization
4

Tumor Response by mRECIST for enhancing tumors

For tumors demonstrating arterial enhancement on pre-treatment imaging, treatment response will be assessed using mRECIST criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.

Time frame
3 months and 6 months after radioembolization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

TriSalus Life Sciences, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: