Surefire Institutional DEB-TACE

Status unconfirmed · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

The purpose of this study is to determine the feasibility and safety of the Surefire Infusion System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in terms of disease response.

Key facts

Study ID

NCT03211598

Run by

Alexander Kim

People needed

15

Starts

2016-10-01

Expected to finish

2020-04-01

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary liver cancers based on biopsy or imaging criteria
• Child-Pugh A or B7 liver disease
• Bilirubin <2.0 mg/dL
• Albumin >3.0 gm/dL
• ECOG status 0 or 1
• Adequate renal function
• a. Creatinine < 2.0 mg/dL
• Age 18 or older
• Able to understand informed consent
• Life expectancy > 3 months
• Women of childbearing potential must have a negative serum/urine pregnancy test on the day of planned procedure.

You may not qualify if…

• Portal vein thrombus
• Uncontrolled ascites
• Hepatic encephalopathy
• Uncorrectable coagulopathy (platelets <50,000, INR >1.50)
• Untreatable contrast allergy
• Pregnancy
• Symptomatic congestive heart failure
• Prior systematic therapy for HCC

Where it is running

• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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