NCT03345225 - A Clinical Study of Precision TACE (P-TACE) With Surefire | Crick

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Conditions

Unresectable Hepatocellular Carcinoma

Interventions

SureFire Infusion SystemDEVICE

Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.

Standard Endhole MicrocatheterDEVICE

A Microcatheter with a single hole at the end for a infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients \> 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy 2. Barcelona Clinic Liver Cancer Classification (BCLC) A or B 3. Child-Pugh Class A or B 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. 1 to 5 target tumors that are \< 6cm with at least one tumor ≥ 3cm in size 6. Vessel size ≥ 1.5 mm 7. Subject must be able to provide written informed consent Exclusion Criteria: 1. Extra-hepatic spread of the cancer 2. Macrovascular tumor invasion 3. Diffuse HCC (\>50% liver involvement) 4. Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s) 5. Advanced liver disease (bilirubin \> 3 mg/dl, aspartate aminotransferase (AST) or ALT \> 5x upper limit of normal or \> 250 U/I 6. Extrahepatic supply to the tumor 7. Hypovascular tumors 8. Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent 9. Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 3 Month

Objective Response Rate as measured by mRECIST