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

University of Miami

Status: Withdrawn

Conditions: Unresectable Hepatocellular Carcinoma

Treatments: Device: Standard Endhole Microcatheter; Device: SureFire Infusion System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03345225

20170185

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter

Treatment:

Device: Standard Endhole Microcatheter

Surefire Group

Experimental group

Description:

Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System

Treatment:

Device: SureFire Infusion System