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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Shannon Kauffman MD, Wright State University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02446925
First Posted: May 18, 2015
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Surefire Medical, Inc.
Information provided by (Responsible Party):
Shannon Kauffman MD, Wright State University
  Purpose
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.

Condition Intervention
Hepatocellular Carcinoma Device: Surefire® Infusion System Device: Standard End-hole catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study

Further study details as provided by Shannon Kauffman MD, Wright State University:

Primary Outcome Measures:
  • Y-90 distribution and concentration as determined by post embolization PET-CT [ Time Frame: Up to 12 months ]
    Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT.


Secondary Outcome Measures:
  • Secondary outcome (length of duration for arteriogram) [ Time Frame: Up to 12 months ]
    length of duration for arteriogram

  • Secondary outcome (fluoro time duration) [ Time Frame: Up to 12 months ]
    fluoro time duration

  • Secondary outcome (number of vessels requiring coiling) [ Time Frame: Up to 12 months ]
    number of vessels requiring coiling

  • Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors) [ Time Frame: 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)) [ Time Frame: 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) [ Time Frame: Up to 12 months ]
    time to progression of tumor

  • Secondary outcome (vessel injury) [ Time Frame: Up to 12 months ]
    vessel injury

  • Secondary outcome (MELD) [ Time Frame: Up to 12 months ]
    Model for End-Stage Liver Disease (MELD)

  • Secondary outcome (CPS) [ Time Frame: Up to 12 months ]
    Childs-Pugh Score (CPS)

  • Secondary outcome (non-target embolization) [ Time Frame: Up to 12 months ]
    non-target embolization

  • Secondary outcome (time to death from first treatment) [ Time Frame: Up to 12 months ]
    time to death from first treatment


Estimated Enrollment: 20
Study Start Date: May 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surefire® Infusion System
Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.
Device: Surefire® Infusion System
Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization
Active Comparator: 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.
Device: Standard End-hole catheter
Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446925


Sponsors and Collaborators
Wright State University
Surefire Medical, Inc.
Investigators
Principal Investigator: Shannon Kauffman, MD Wright State University Boonshoft School of Medicine
  More Information

Publications:
Responsible Party: Shannon Kauffman MD, Wright State University
ClinicalTrials.gov Identifier: NCT02446925     History of Changes
Other Study ID Numbers: Surefire-LCC 1.0
First Submitted: May 7, 2015
First Posted: May 18, 2015
Last Update Posted: November 15, 2016
Last Verified: May 2015

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases