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DEB-TACE for Hepatocellular Carcinoma (QED)

This study is currently recruiting participants.
Verified October 2017 by Surefire Medical, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748161
First Posted: April 22, 2016
Last Update Posted: November 1, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Surefire Medical, Inc.
  Purpose

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 Intervention
Hepatocellular Carcinoma Procedure: DEB-TACE

Study Type: Interventional
Study Design: 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)

Further study details as provided by Surefire Medical, Inc.:

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

Secondary Outcome Measures:
  • Objective tumor response [ Time Frame: 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: 3 months following initial DEB-TACE procedure ]
  • Contrast dose [ Time Frame: DEB-TACE procedure(s) ]
  • Fluoroscopic time [ Time Frame: DEB-TACE procedure(s) ]
  • Number of repeat DEB-TACE procedures per lesion [ Time Frame: 3 months following initial DEB-TACE procedure ]
  • Post DEB-TACE conebeam CT measurement of contrast retention in tumor [ Time Frame: DEB-TACE procedure(s) ]
  • Changes in alpha-fetoprotein (AFP) blood levels [ Time Frame: 1 & 3 months following initial DEB-TACE procedure ]

Estimated Enrollment: 170
Study Start Date: August 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation.
  • Meets Milan Criteria: single tumor ≤ 5 cm, or maximum of 3 total tumors with each ≤ 3 cm AND/OR, meets UCSF criteria: a single lesion < 6.5 cm in diameter or 2-3 lesions < 4.5 cm with total tumor diameter < 8 cm.
  • No portal invasion or extrahepatic spread on imaging.
  • Child's 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, and preserved liver function (Child-Pugh Class A or B).
  • Has a discrete hepatic artery feeding the tumor with diameter of the vessels greater than 1.5 mm.

Exclusion Criteria:

  • Advanced 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.
  • Child's Class C.
  • Vessels providing flow to the tumor that are less than 1.5 mm in diameter.
  • Patient has a known history contraindicating contrast dye or iodine that cannot be safely controlled via antihistamine, steroids, or with any other agent.
  • Unable to provide informed consent.
  • Women who are pregnant or currently 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).
  • Exclusion criteria includes portal vein thrombosis of bland or malignant origin.
  Contacts and Locations
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


Contacts
Contact: Vickie Arford, RN 901-485-7106 vickie.arford@surefiremedical.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States
Principal Investigator: Ahmed Kamel, MD         
United States, Arizona
University of Arizona Recruiting
Phoenix, Arizona, United States
Principal Investigator: Steven Chen, MD         
United States, California
UCLA Recruiting
Los Angeles, California, United States
Principal Investigator: Justin McWilliams, MD         
USC Recruiting
Los Angeles, California, United States
Principal Investigator: Michael Katz, MD         
United States, Colorado
Radiology Imaging Associates Recruiting
Denver, Colorado, United States
Principal Investigator: Dominic Yee, MD         
United States, District of Columbia
Georgetown University Recruiting
Washington, D.C., District of Columbia, United States
Principal Investigator: Alex Kim, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States
Principal Investigator: Ahkter Nabeel, MD         
United States, New York
New York University Recruiting
New York, New York, United States
Principal Investigator: Eric Aaltonen, MD         
United States, Ohio
Cleveland Clinical Foundation Recruiting
Cleveland, Ohio, United States
Principal Investigator: Baljendra Kapoor, MD         
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States
Principal Investigator: Jon Davidson, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States
Principal Investigator: Ryan O'Hara, MD         
Sponsors and Collaborators
Surefire Medical, Inc.
  More Information

Responsible Party: Surefire Medical, Inc.
ClinicalTrials.gov Identifier: NCT02748161     History of Changes
Other Study ID Numbers: HP-00061366
First Submitted: April 18, 2016
First Posted: April 22, 2016
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Surefire Medical, Inc.:
Hepatocellular carcinoma
DEB-TACE
QED

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Chlorotrianisene
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents