We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

DEB-TACE for Hepatocellular Carcinoma (QED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02748161
Recruitment Status : Terminated (Low enrollment)
First Posted : April 22, 2016
Last Update Posted : June 21, 2018
Information provided by (Responsible Party):
SurefireMedical ( Surefire Medical, Inc. )

Brief Summary:

Patients enrolled in this study have been diagnosed with hepatocellular carcinoma (HCC) and are scheduled to have a procedure called drug-eluting bead trans-arterial chemoembolization (DEB-TACE). During the DEB-TACE procedure, very small beads are mixed in with a chemotherapy drug, doxorubicin, and delivered to the tumor through an arterial catheter.

The DEB-TACE procedure allows the treatment to be delivered directly into the liver. It also causes arterial embolization, the process in which a blood vessel is blocked. Treatment of HCC using DEB-TACE may help delay tumor progression and can downstage (decrease the size) the cancer in order to meet the criteria which may allow patients to become candidates for liver transplantation. The purpose of this study is to compare tumor response and medical outcomes for patients who undergo DEB-TACE with standard endhole catheter versus Surefire® Infusion System.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: DEB-TACE Not Applicable

Detailed Description:

Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). TACE with doxorubicin-eluting beads (DEB-TACE) is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE and studies have documented its safety and efficacy. DEB-TACE is currently utilized for: (1) patients who have unresectable HCC; and (2) patients who meet the Milan Criteria and currently on liver transplantation lists.

The biggest challenge for these procedures has been the inability to actually quantify embolization in a real-time setting to provide immediate feedback to the operator. Although various methods, such as perfusion analysis with CT or MRI, have been described, these require advanced imaging equipment/capabilities, extensive post processing analysis, and can create challenging workflows.

Currently the best results occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by CT has been shown to have improved outcomes. However, with standard endhole catheters achieving maximum delivery of embolic agents is limited by the development of stasis and subsequent non-target injury.

As DEB-TACE is performed through an endhole catheter with either stasis or substasis as an endpoint. The current methodology is extremely subjective, lacks a quantifiable endpoint, and results in various degrees of embolization on patients. Often this can result in repeat procedures or the progression of tumor.

Recently, there has been FDA clearance of a new anti-reflux catheter, Surefire® Infusion System (SIS, Westminster, CO). The current design has an expandable tip which collapses during forward flow, and then dynamically seal off the vessel with reversal of flow, analogous to a valve. SIS, with its expandable tip microcatheter, has been demonstrated clinically to cause a slight decrease in intra-arterial pressure in the antegrade, or downstream, vascular compartment. Although this device was designed primarily to prevent retrograde reflux of embolic agents, the downstream blood pressure reduction may serve as a biomarker on quantifying embolization.

The goal is to develop a method that: (1) allows maximum delivery of embolic spheres into the tumor tissue to stasis without reflux; (2) enables direct real time numerical quantification on the degree of embolization; and (3) provides an intra-procedural functional parameter which could be used to guide the optimal therapeutic endpoints at the time of treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes by Comparing Two Different Catheter Systems for DEB-TACE (QED Study)
Study Start Date : August 2015
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : June 15, 2018

Arm Intervention/treatment
Active Comparator: DEB-TACE: Standard Endhole Catheter
Subjects will undergo DEB-TACE using a standard endhole catheter.
Procedure: DEB-TACE
Transarterial chemoembolization with doxorubicin-eluting beads.

Active Comparator: DEB-TACE: Surefire Infusion System
Subjects will undergo DEB-TACE using the Surefire Infusion System.
Procedure: DEB-TACE
Transarterial chemoembolization with doxorubicin-eluting beads.

Primary Outcome Measures :
  1. Objective tumor response [ Time Frame: 1 month following initial DEB-TACE procedure ]

Secondary Outcome Measures :
  1. Objective tumor response [ Time Frame: 3 months following initial DEB-TACE procedure (or 1 month following retreatment if DEB-TACE retreatment performed) ]
  2. Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s) [ Time Frame: Procedure ]
  3. Number of repeat DEB-TACE procedures per lesion [ Time Frame: 3 months following initial DEB-TACE procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 years or older, inclusive
  • Diagnosis of HCC
  • Meets UCSF criteria: a single lesion less than or equal to 6.5 cm in diameter or 2-3 lesions less than or equal to 4.5 cm with total tumor diameter less than or equal to 8 cm.
  • No portal invasion or extrahepatic spread on imaging.
  • Child-Pugh Class A or B.
  • No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy).
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm.

Exclusion Criteria:

  • Bilirubin levels greater than 3 mg/dl
  • AST or ALT greater than 5 times upper limit of normal or greater than 250 U/l.
  • Advanced tumoral disease (vascular invasion or extrahepatic spread, portal vein thrombosis of bland or malignant origin), or diffuse HCC, defined as 50% liver involvement).
  • Contraindications for doxorubicin administration.
  • Subject has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
  • Unable or unwilling to provide informed consent.
  • Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
  • Women who are pregnant or breast feeding.
  • Women of childbearing potential who are not using an acceptable method of birth control (e.g., pill, patch, IUD, ring, condom, sponge, foam).
  • Portal vein thrombosis of bland or malignant origin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748161

Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States
United States, Arizona
University of Arizona
Phoenix, Arizona, United States
United States, California
Los Angeles, California, United States
Los Angeles, California, United States
United States, Colorado
Radiology Imaging Associates
Denver, Colorado, United States
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States
United States, Maryland
University of Maryland
Baltimore, Maryland, United States
United States, New York
New York University
New York, New York, United States
United States, Ohio
Cleveland Clinical Foundation
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Surefire Medical, Inc.
Layout table for additonal information
Responsible Party: Surefire Medical, Inc.
ClinicalTrials.gov Identifier: NCT02748161    
Other Study ID Numbers: HP-00061366
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SurefireMedical ( Surefire Medical, Inc. ):
Hepatocellular carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases