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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: Surefire® Infusion System
* Device: Standard End-hole catheter


Participation Criteria
=================
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, 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surefire® Infusion System<br>Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter. | Device: Surefire® Infusion System<br>* Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization<br>|
| Active Comparator: Standard End-hole catheter<br>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<br>* Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization<br>|

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 |