TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05743842

Enrollment

Registered

2023-02-24

Start date

2023-03-14

Completion date

2027-12-31

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Brief summary

To learn if using the TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.

Detailed description

Primary Objectives: To determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative SPECT/CT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device. Secondary Objectives: To determine the correlation of T:N ratios of all tumors 3cm based on 99mTc-MAA SPECT/CT and Y90 SPECT/CT imaging. To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECT/CT. To assess safety of TriNav catheter in this study population

Interventions

DEVICETriSalus™ TriNav™Infusion System

Given by Infusion

DIAGNOSTIC_TESTAngiogram

X-ray photograph

PROCEDUREY90-radioembolization procedure

procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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, and must be non-pregnant with an acceptable contraception in premenopausal women. * At least one lesion ≥ 3.0 cm in shortest dimension * Negative pregnancy test in premenopausal women

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 injection. * 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 * Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORArmeen Mahvash, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026