DEB-TACE for Hepatocellular Carcinoma (QED)

June 19, 2018 updated by: Surefire Medical, Inc.

Surefire vs. Endhole for DEB-TACE: Quantifying Hepatic Artery Embolization to Improve Outcomes by Comparing Two Different Catheter Systems for DEB-TACE (QED Study)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States
        • University of Arizona
    • California
      • Los Angeles, California, United States
        • UCLA
      • Los Angeles, California, United States
        • USC
    • Colorado
      • Denver, Colorado, United States
        • Radiology Imaging Associates
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland
    • New York
      • New York, New York, United States
        • New York University
    • Ohio
      • Cleveland, Ohio, United States
        • University Hospitals Of Cleveland
      • Cleveland, Ohio, United States
        • Cleveland Clinical Foundation
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response
Time Frame: 1 month following initial DEB-TACE procedure
1 month following initial DEB-TACE procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surefire Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00061366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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