Hepatocellular Carcinoma
Conditions
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.
Interventions
DEVICESurefire® Infusion System
Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization
DEVICEStandard End-hole catheter
Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization
Sponsors
Surefire Medical, Inc.
Wright State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Y-90 distribution and concentration as determined by post embolization PET-CT | Up to 12 months | Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome (fluoro time duration) | Up to 12 months | fluoro time duration |
| Secondary outcome (number of vessels requiring coiling) | Up to 12 months | number of vessels requiring coiling |
| Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors) | Up to 12 months | tumor response by Response Evaluation Criteria in Solid Tumors (m-RECIST criteria) |
| Secondary outcome- 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 | toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP)) |
| Secondary outcome (time to progression of tumor) | Up to 12 months | time to progression of tumor |
| Secondary outcome (length of duration for arteriogram) | Up to 12 months | length of duration for arteriogram |
| Secondary outcome (MELD) | Up to 12 months | Model for End-Stage Liver Disease (MELD) |
| Secondary outcome (CPS) | Up to 12 months | Childs-Pugh Score (CPS) |
| Secondary outcome (non-target embolization) | Up to 12 months | non-target embolization |
| Secondary outcome (time to death from first treatment) | Up to 12 months | time to death from first treatment |
| Secondary outcome (vessel injury) | Up to 12 months | vessel injury |
Outcome results
None listed