PREDICTT Clinical Trial: Prospective Evaluation Of Pressure-Enabled Delivery And Alterations In CT-Based Tumor-To-Normal Liver Ratio And Tumor Dose Using The Trinav Infusion System

February 26, 2026 updated by: M.D. Anderson Cancer Center
This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

Primary Objective #1: To evaluate the alterations in CT-based relative enhancement ratio from non-contrast to post-contrast CT imaging in the tumor and normal liver with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device aka TriNav Infusion System.

Secondary Objectives:

To evaluate the correlation of CT-based relative enhancement with tumor to normal liver ratio (TNR) from Tc99m-MAA SPECT/CT mapping study, and tumor dose (TD), nontumoral liver dose (NTLD), and tumor microparticle load from the post-Y90 treatment SPECT/CT in patients mapped and treated with TriNav Infusion System.

To assess safety of TriNav catheter in this study population

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M. D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Peiman Habibollahi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months
  3. At least one lesion ≥ 3.0 cm in shortest dimension
  4. Negative pregnancy test in premenopausal women with an acceptable contraception
  5. Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry
  6. Evidence of partial or complete tumor vascularity based on pre-procedure liver protocol CT scan or MRI with contrast or intraprocedural hybrid angio CT as well as subjectively similar tumor vascularity between right and left lobes if bilobar treatment is planned
  7. Right or left hepatic artery diameter of 1.5 mm to 5 mm (the recommended vessel size range for the TriNav Infusion System) based on pre-procedure arterial phase CT or intraprocedural hybrid angio CT

Exclusion Criteria:

  1. Contraindications to angiography and selective visceral catheterization
  2. Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session
  3. CT based TNR of 3 or higher based on planning hybrid angioCT
  4. 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)
  5. Infiltrative tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm Y90 Radioembolization
Will show an increase of TNR and TD as well as a reduction in NTLD by TriNav microcatheter.
Device: Y90 Microsphere Therapy
Given by injection
Other Names:
  • Radioembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

TriSalus Life Sciences, Inc.

Investigators

  • Principal Investigator: Peiman Habibollahi, MD, M.D. Anderson Cancer Center
  • Principal Investigator: S. Cheenu Kappadath, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1756
  • NCI-2026-01389 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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