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

Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: Surefire® Infusion System; Device: Standard End-hole catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Participation Criteria

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:

• 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,
• Patients who meet the standard Y-90 exclusion criteria according to package insert
• Female patients who are pregnant
• Patients under the age of 18
• Patients who are unable to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Surefire® Infusion System; Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.	Device: Surefire® Infusion System; Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization
ACTIVE_COMPARATOR: 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.	Device: Standard End-hole catheter; Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Y-90 distribution and concentration as determined by post embolization PET-CT	Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome (length of duration for arteriogram)	length of duration for arteriogram	Up to 12 months
Secondary outcome (fluoro time duration)	fluoro time duration	Up to 12 months
Secondary outcome (number of vessels requiring coiling)	number of vessels requiring coiling	Up to 12 months
Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors)	tumor response by Response Evaluation Criteria in Solid Tumors (m-RECIST criteria)	Up to 12 months
Secondary outcome- toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))	toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))	Up to 12 months
Secondary outcome (time to progression of tumor)	time to progression of tumor	Up to 12 months
Secondary outcome (vessel injury)	vessel injury	Up to 12 months
Secondary outcome (MELD)	Model for End-Stage Liver Disease (MELD)	Up to 12 months
Secondary outcome (CPS)	Childs-Pugh Score (CPS)	Up to 12 months
Secondary outcome (non-target embolization)	non-target embolization	Up to 12 months
Secondary outcome (time to death from first treatment)	time to death from first treatment	Up to 12 months

Collaborators and Investigators

• Sponsor: Wright State University
• Collaborators: Surefire Medical, Inc.
• Investigators: Principal Investigator: Shannon Kauffman, MD, Wright State University Boonshoft School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): December 19, 2018
• Study Completion (ACTUAL): December 19, 2018

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (ESTIMATE): May 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: Advarra - 42093