NCT05743842

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DEVICE	TriSalus™ TriNav™Infusion System	Given by Infusion
DIAGNOSTIC_TEST	Angiogram	X-ray photograph
PROCEDURE	Y90-radioembolization procedure	procedure

Timeline

• Start date: 2023-03-14
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-02-24
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States