Surefire Institutional DEB-TACE

NCT03211598 | Unknown DMC

• 1 other identifier: SF Georgetown
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Stasis of flow in target vessel as seen on digital subtraction angiography or cone-beam CT, or reflux of particles despite the use of SIS.

  Assess the technical feasibility of performing TACE using the SIS. If stasis of flow is not reached after 1 vial of DEB, further bland embolization will be performed until stasis is reached or earlier as determined adequate by the treating interventional radiologist.

  During chemoembolization

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Assess the safety of SIS for TACE as per CTCAE v 4.03

  Duration of study (12 months)

Secondary Outcomes (3)

• Tumor Assessment via MRI Imaging

  Duration of study (12 months)

• Tumor Assessment via CT Imaging

  Duration of study (12 months)

• FACT Hep4 Questionnaire

  Visit 5 (week 5)

Study Arms (1)

TACE with Surefire

OTHER

Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System.

Procedure: TACE with Surefire

Interventions

TACE with Surefire PROCEDURE

Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System

TACE with Surefire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alexander Kim: lead
• Surefire Medical, Inc.: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

• Lee KK, Kim DG, Moon IS, Lee MD, Park JH. Liver transplantation versus liver resection for the treatment of hepatocellular carcinoma. J Surg Oncol. 2010 Jan 1;101(1):47-53. doi: 10.1002/jso.21415.

  PMID: 19798686 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Alexander Y Kim, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Interventional Radiology at Medstar Georgetown University Hospital

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: July 7, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

US (1)