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

Wright State University

Status: Terminated

Conditions: Hepatocellular Carcinoma

Treatments: Device: Standard End-hole catheter; Device: Surefire® Infusion System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02446925

Advarra - 42093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Surefire® Infusion System

Experimental group

Description:

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

Treatment:

Device: Surefire® Infusion System

Standard End-hole catheter

Active Comparator group

Description:

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

Treatment:

Device: Standard End-hole catheter