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

Liver Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05743842
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Armeen Mahvash, MD
Phone 713-563-7340
Email armeen.mahvash@mdanderson.org
Status Recruiting
Phase N/A
Start date March 14, 2023
Completion date December 31, 2027
View Details
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