A Clinical Study of Precision TACE (P-TACE) With Surefire

Study Overview
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Brief Summary
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The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).

Official Title
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A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)

Conditions
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Unresectable Hepatocellular Carcinoma

Intervention / Treatment
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* Device: SureFire Infusion System
* Device: Standard Endhole Microcatheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy Barcelona Clinic Liver Cancer Classification (BCLC) A or B Child-Pugh Class A or B Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 1 to 5 target tumors that are < 6cm with at least one tumor ≥ 3cm in size Vessel size ≥ 1.5 mm Subject must be able to provide written informed consent Exclusion Criteria: Extra-hepatic spread of the cancer Macrovascular tumor invasion Diffuse HCC (>50% liver involvement) Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s) Advanced liver disease (bilirubin > 3 mg/dl, aspartate aminotransferase (AST) or ALT > 5x upper limit of normal or > 250 U/I Extrahepatic supply to the tumor Hypovascular tumors Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter | Device: Standard Endhole Microcatheter<br>* A Microcatheter with a single hole at the end for a infusion.<br>|
| Experimental: Surefire Group<br>Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System | Device: SureFire Infusion System<br>* Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter | The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Lencioni Score (LS) | The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage. | 3 months | 
| The Lencioni Score (LS) | The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage. | 6 months | 
| Objective Response Rate as measured by mRECIST | Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions | 1 Month | 
| Objective Response Rate as measured by mRECIST | Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions | 3 Month | 
| Objective Response Rate as measured by mRECIST | Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions | 6 Month | 
| Distribution of Radiopaque beads | Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms | 1 Month | 
| Distribution of Radiopaque beads | Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms | 3 Month | 
| Distribution of Radiopaque beads | Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms | 6 Month | 
| Tumor enhancement | Comparing tumor enhancement relative to a calibrated imaging phantom | 1 month | 
| Tumor enhancement | Comparing tumor enhancement relative to a calibrated imaging phantom | 3 month | 
| Tumor enhancement | Comparing tumor enhancement relative to a calibrated imaging phantom | 6 month | 
| Number of Adverse Event | Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Chemoembolization (TACE), Liver Cancer