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

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

This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.

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

Inclusion Criteria:

1. 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
2. Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months
3. At least one lesion ≥ 3.0 cm in shortest dimension
4. Negative pregnancy test in premenopausal women with an acceptable contraception
5. Plan to perform bilobar, lobar or sectoral treatment using partition dosimetry
6. 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
7. 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:

1. Contraindications to angiography and selective visceral catheterization
2. Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session
3. CT based TNR of 3 or higher based on planning hybrid angioCT
4. 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)
5. Infiltrative tumors