Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Device: Standard End-hole catheterDevice: Surefire® Infusion System
- Registration Number
- NCT02446925
- Lead Sponsor
- Wright State University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard End-hole catheter 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. Surefire® Infusion System Surefire® Infusion System Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary outcome (length of duration for arteriogram) Up to 12 months length of duration for arteriogram
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 (vessel injury) Up to 12 months vessel injury
Secondary outcome (non-target embolization) Up to 12 months non-target embolization
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 (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 (time to death from first treatment) Up to 12 months time to death from first treatment
Secondary outcome (time to progression of tumor) Up to 12 months time to progression of tumor