Unresectable Hepatocellular Carcinoma
Conditions
Keywords
Chemoembolization (TACE), HCC, Liver Cancer
Brief summary
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).
Interventions
DEVICESureFire Infusion System
Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
DEVICEStandard Endhole Microcatheter
A Microcatheter with a single hole at the end for a infusion.
Sponsors
Surefire Medical, Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor enhancement | 1 month | Comparing tumor enhancement relative to a calibrated imaging phantom |
| The Lencioni Score (LS) | 3 months | 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. |
| Objective Response Rate as measured by mRECIST | 1 Month | 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 |
| Distribution of Radiopaque beads | 1 Month | 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 |
| Number of Adverse Event | 6 months | Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE) |
Countries
United States
Outcome results
None listed