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
M.D. Anderson Cancer Center
Summary
This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.
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 Tr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 vasculari…
Interventions
- DeviceY90 Microsphere Therapy
Given by injection
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas