Surefire Precision Infusion System Registry

Hepatocellular Carcinoma Clinical Trial

Official title:

Surefire Precision Infusion System Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02967523
• Other study ID #: 26 October 2016
• Status: Terminated
• Start date: May 2016
• Est. completion date: June 18, 2018

Study information

• Verified date: September 2018
• Source: Surefire Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This project involves the collection and analysis of retrospective and prospective data on patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision Infusion System was used/will used be to deliver transarterial chemoembolization with doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in a real-world setting as well as identify potential areas for future clinical research.

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). The best results for cTACE 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 computed tomography (CT) has been shown to have improved outcomes. However, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. Thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. Therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints.

DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria for possible liver transplantation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: June 18, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have undergone or will undergo DEB-TACE for HCC delivered by the Surefire® Precision Infusion System

• Patients aged 18 years or older

• Diagnosis of HCC

• Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels = 1.5 mm

Exclusion Criteria:

• Contraindications for doxorubicin administration

• Vessels providing flow to the tumor that are < 1.5 mm in diameter(s)

• Patients who are unable to provide informed consent

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• DEB-TACE with Surefire Precision Infusion System
Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	UCLA	Los Angeles	California
United States	USC	Los Angeles	California
United States	Florida Hospital	Orlando	Florida
United States	University of Utah	Salt Lake City	Utah
United States	UCSD	San Diego	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Surefire Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response		6 months following initial DEB-TACE procedure.
Secondary	Objective tumor response		1 and 3 months following initial DEB-TACE procedure
Secondary	Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)		6 months following initial DEB-TACE procedure
Secondary	Tumor characteristics	Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse)	DEB-TACE procedure(s)
Secondary	Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)		DEB-TACE procedure(s)
Secondary	Changes in alpha-fetoprotein (AFP) blood levels		1, 3 and 6 months following initial DEB-TACE procedure