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

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03345225
• Other study ID #: 20170185
• Status: Withdrawn
• Phase: N/A
• Start date: May 2018
• Est. completion date: November 2021

Study information

• Verified date: September 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Device:
• SureFire 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.
• Standard Endhole Microcatheter
A Microcatheter with a single hole at the end for a infusion.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Surefire Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Tumor enhancement	Comparing tumor enhancement relative to a calibrated imaging phantom	1 month
Secondary	Tumor enhancement	Comparing tumor enhancement relative to a calibrated imaging phantom	3 month
Secondary	Tumor enhancement	Comparing tumor enhancement relative to a calibrated imaging phantom	6 month
Secondary	Number of Adverse Event	Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE)	6 months