PREDICTT Clinical Trial: Prospective Evaluation Of Pressu... | NCT07444645

ID	Type	Description	Link
NCI-2026-01389	Other Identifier	NCI-CTRP Clinical Trials Registry

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Jul 31, 2028Estimated

Completion Date

Jul 31, 2030Estimated

First Submitted Date

Feb 26, 2026

First Submission Date that Met QC Criteria

Feb 26, 2026

First Posted Date

Mar 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2026

Last Update Posted Date

Mar 3, 2026Actual

Name	Class
TriSalus Life Sciences, Inc.	INDUSTRY

Description Module

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 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Y90 Microsphere Therapy	Device	Given by injection	Single Arm Y90 Radioembolization

Outcomes Module

Primary Outcomes

Measure	Description	Time 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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peiman Habibollahi, MD	Contact	(713) 792-4106		phabibollahi@mdanderson.org

Overall Officials

Name	Affiliation	Role
Peiman Habibollahi, MD	M.D. Anderson Cancer Center	Principal Investigator
S. Cheenu Kappadath, PHD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas M. D. Anderson Cancer Center		Houston	Texas	77030	United States