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

NCT07444645 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 2025-1756NCI-2026-01389
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.

Conditions

Tumor; Liver

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  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

Study Arms (1)

Single Arm Y90 Radioembolization

EXPERIMENTAL

Will show an increase of TNR and TD as well as a reduction in NTLD by TriNav microcatheter.

Device: Y90 Microsphere Therapy

Interventions

Y90 Microsphere Therapy DEVICE

Given by injection

Also known as: Radioembolization

Single Arm Y90 Radioembolization

Eligibility Criteria

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

You may qualify if:

• 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
• Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months
• At least one lesion ≥ 3.0 cm in shortest dimension
• Negative pregnancy test in premenopausal women with an acceptable contraception
• Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• TriSalus Life Sciences, Inc.: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Study Officials

• Peiman Habibollahi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• S. Cheenu Kappadath, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peiman Habibollahi, MD

CONTACT

(713) 792-4106; phabibollahi@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)