This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients. The names of the study interventions involved in this study are: -Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire
This research study is a randomized Pilot study, which is the first time investigators are examining use of the TriNav device to improve tumor perfusion. Specifically, this study compares TACE both with or without the use of the TriNav device Investigators are doing this research to determine if a TriNav Infusion System can improve tumor response to liver-directed intra-arterial chemotherapy compared to a traditional microcatheter. TriNav is a Food and Drug Administration-approved valve-like device that blocks backflow within the artery but also generates increased pressure in a tumor feeder vessel during infusion. During this study, participants will receive the same medication in the same dose and the same way it would be delivered to the liver as a standard of care procedure, only either through a regular microcatheter (which is the standard of care procedure) or a TriNav Infusion System (which is a modified microcatheter).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
TriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.
Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Capillary permeability (Ktrans) calculated by software that analyzes enhancement on post-contrast MRI.
Ktrans represents a calculated metric that represents a measure of capillary permeability obtained during dynamic contrast enhanced MRI; it represents an absolute value of tracer concentration within the tissue of interest. It is calculated by measuring the accumulation of contrast agent on post-contrast MR images within a given tissue over time and comparing it to a baseline contrast-filled structure such as a blood vessel. The measurement represents accumulation of contrast for a given tissue, as determined by the investigator. Normality of the distribution will be tested using Shapiro-Wilk test. To compare Ktrans, the investigators will apply t-test or Wilcoxon rank sum test as appropriate.
Time frame: 2 years
Extravascular extracellular volume fraction (ve) calculated by software that analyzes enhancement on post-contrast MRI.
Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the tissue of interest, similar to Ktrans.
Time frame: 2 years
Rate constant (kep)
Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents a derived value (kep = ktrans/ve) and is dependent upon ktrans and ve.
Time frame: 2 years
Plasma volume (vp) calculated by software that analyzes enhancement on post-contrast MRI.
Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the plasma and allows for more accurate measurement of tissue permeability.
Time frame: 2 years
Time To Tumor Progression
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Time frame: 2 years