Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

NCT ID: NCT02446925

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2018-12-19

Brief Summary

The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.

Detailed Description

Yttrium-90 (Y-90) radioembolization is a minimally invasive trans-arterial treatment for primary and secondary hepatic malignancies that relies on tumor hypervascularity for concentration of radioactive microspheres. The Surefire® Infusion System (SIS) (Westminster, CO) was developed to reduce non-target embolization which can result in morbid complications, especially those involving radioembolic or drug eluting microspheres. Prior to its introduction, radioembolization and other trans-arterial therapies have been performed with standard end-hole catheters. In addition to providing protection against non-target embolization, studies have demonstrated improved penetration of embolic material (tantalum microspheres and Tc-99M labeled MAA) with the use of the SIS when compared to conventional end-hole catheters. To date, no study has demonstrated improved distribution and penetration of yttrium-90 glass microspheres with the use of the Surefire catheter versus a standard end-hole catheter. Y-90 distribution can be evaluated with the use of immediate post-delivery PET/CT imaging as it creates its own pair production and can be imaged in the immediate post delivery period. PET/CT will demonstrate distribution and the dose to tumors can be calculated. The investigators propose a pilot study comparing yttrium-90 tumor distribution and concentration in patients with hepatocellular carcinoma (HCC) with the use of the SIS versus a standard end-hole catheter.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Surefire® Infusion System

Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.

Group Type: EXPERIMENTAL

Surefire® Infusion System

Intervention Type: DEVICE

Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization

Standard End-hole catheter

Patients randomized to the standard end-hole catheter treatment arm will undergo Y-90 glass microsphere embolization with a standard end-hole catheter.

Group Type: ACTIVE_COMPARATOR

Standard End-hole catheter

Intervention Type: DEVICE

Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

Interventions

Surefire® Infusion System

Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization

Intervention Type: DEVICE

Standard End-hole catheter

Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Lobar-only treatments
• Patients with biopsy or radiographically proven hepatocellular carcinoma who are not candidates for transplant, surgical resection or ablative therapy
• Patients 18 years of age and older
• Patients who are able to provide written informed consent

Exclusion Criteria

• Patients with Barcelona-Clinic Liver Cancer (BCLC) Stage C disease,
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3,
• Patients who are unable to tolerate Y-90,
• Patients with arterial anatomy unsuitable to place Surefire catheter,
• Patients with uncorrectable coagulopathy,
• Patients with platelets less than 50 (uncorrectable),
• Bilirubin >3 mg/dl,
• AST or ALT>5x upper limit of normal,
• Patients who are unable to tolerate angiography,
• Patients with < 3 months to live,
• Female patients who are pregnant
• Patients under the age of 18
• Patients who are unable to provide written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surefire Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Wright State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon Kauffman, MD

Role: PRINCIPAL_INVESTIGATOR

Wright State University Boonshoft School of Medicine

References

Arepally A, Chomas J, Kraitchman D, Hong K. Quantification and reduction of reflux during embolotherapy using an antireflux catheter and tantalum microspheres: ex vivo analysis. J Vasc Interv Radiol. 2013 Apr;24(4):575-80. doi: 10.1016/j.jvir.2012.12.018. Epub 2013 Feb 23.

Reference Type: BACKGROUND

PMID: 23462064 (View on PubMed)

Other Identifiers

Advarra - 42093

Identifier Type: -

Identifier Source: org_study_id