Status:
WITHDRAWN
A Clinical Study of Precision TACE (P-TACE) With Surefire
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Surefire Medical, Inc.
Conditions:
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Patients \> 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
- Barcelona Clinic Liver Cancer Classification (BCLC) A or B
- Child-Pugh Class A or B
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- 1 to 5 target tumors that are \< 6cm with at least one tumor ≥ 3cm in size
- Vessel size ≥ 1.5 mm
- Subject must be able to provide written informed consent
Exclusion
- Extra-hepatic spread of the cancer
- Macrovascular tumor invasion
- Diffuse HCC (\>50% liver involvement)
- Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
- Advanced liver disease (bilirubin \> 3 mg/dl, aspartate aminotransferase (AST) or ALT \> 5x upper limit of normal or \> 250 U/I
- Extrahepatic supply to the tumor
- Hypovascular tumors
- Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
- Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03345225
Start Date
May 1 2018
End Date
November 1 2021
Last Update
September 11 2018
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136