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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 20

Not yet recruiting
Clinical Trial NCT07444645 is an interventional study for Tumor, Liver and is currently not yet recruiting. Enrollment is planned to begin on August 1, 2026 and continue until the study accrues 20 participants. Led by M.D. Anderson Cancer Center, this study is expected to complete by July 31, 2030. The latest data from ClinicalTrials.gov was last updated on March 3, 2026.
Brief Summary
This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.
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...

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Official Title

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

Conditions
TumorLiver
Other Study IDs
  • 2025-1756
  • NCI-2026-01389 (Other Identifier) (NCI-CTRP Clinical Trials Registry)
NCT ID Number
NCT07444645
Start Date (Actual)
2026-08-01
Last Update Posted
2026-03-03
Completion Date (Estimated)
2030-07-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Device Feasibility
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSingle Arm Y90 Radioembolization
Will show an increase of TNR and TD as well as a reduction in NTLD by TriNav microcatheter.
Y90 Microsphere Therapy
Given by injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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
M.D. Anderson Cancer Center logoM.D. Anderson Cancer Center
TriSalus Life Sciences, Inc. logoTriSalus Life Sciences, Inc.
Study Central Contact
Contact: Peiman Habibollahi, MD, (713) 792-4106, [email protected]
1 Study Locations in 1 Countries

Texas

The University of Texas M. D. Anderson Cancer Center, Houston, Texas, 77030, United States
Peiman Habibollahi, MD, Contact, 713-792-4106, [email protected]
Peiman Habibollahi, MD, Principal Investigator