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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Y90 Microsphere Therapy.
- Who it may be relevant to
- Registry conditions: Tumor, Liver. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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
Interventions
- Device Y90 Microsphere Therapy
Given by injection
Primary outcome measures
- Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- The University of Texas M. D. Anderson Cancer Center — Houston
Identifiers
NCT: NCT07444645 · 2025-1756 · NCI-2026-01389