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

Not Applicable

Withdrawn

• Conditions: Unresectable Hepatocellular Carcinoma
• Interventions: Device: Standard Endhole Microcatheter; Device: SureFire Infusion System

• Registration Number: NCT03345225
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Study Start: 2018-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11
• Primary Completion: 2021-05
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Endhole Microcatheter	Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter
Surefire Group	SureFire Infusion System	Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Tumor enhancement	6 month	Comparing tumor enhancement relative to a calibrated imaging phantom
The Lencioni Score (LS)	6 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.
Distribution of Radiopaque beads	6 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)
Objective Response Rate as measured by mRECIST	6 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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States