Clinical trial NCT02446925: Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study
Official title: Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Wright State University
Sponsor class: OTHER
Collaborators: name: Surefire Medical, Inc.
First posted: 2015-05-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Y-90 distribution and concentration as determined by post embolization PET-CT
timeFrame: Up to 12 months
Secondary outcomes:
measure: Secondary outcome (length of duration for arteriogram)
timeFrame: Up to 12 months
measure: Secondary outcome (fluoro time duration)
timeFrame: Up to 12 months
measure: Secondary outcome (number of vessels requiring coiling)
timeFrame: Up to 12 months
measure: Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors)
timeFrame: Up to 12 months
measure: Secondary outcome- toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))
timeFrame: Up to 12 months
measure: Secondary outcome (time to progression of tumor)
timeFrame: Up to 12 months
measure: Secondary outcome (vessel injury)
timeFrame: Up to 12 months
measure: Secondary outcome (MELD)
timeFrame: Up to 12 months
measure: Secondary outcome (CPS)
timeFrame: Up to 12 months
measure: Secondary outcome (non-target embolization)
timeFrame: Up to 12 months
measure: Secondary outcome (time to death from first treatment)
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wright State University Boonshoft School of Medicine
name: Shannon Kauffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.