NCT02446925

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started May 2015

Typical duration for not_applicable hepatocellular-carcinoma

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

3.6 years

First QC Date

May 7, 2015

Last Update Submit

July 25, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Secondary outcome (length of duration for arteriogram)

    Up to 12 months

  • Secondary outcome (fluoro time duration)

    Up to 12 months

  • Secondary outcome (number of vessels requiring coiling)

    Up to 12 months

  • Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors)

    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))

    Up to 12 months

  • +6 more secondary outcomes

Study Arms (2)

Surefire® Infusion System

EXPERIMENTAL

Patients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.

Device: Surefire® Infusion System

Standard End-hole catheter

ACTIVE COMPARATOR

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

Interventions

Surefire® Infusion SystemDEVICE

Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization

Surefire® Infusion System
Standard End-hole catheterDEVICE

Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

Standard End-hole catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • Female patients who are pregnant
  • Patients under the age of 18
  • Patients who are unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23462064BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Shannon Kauffman, MD

    Wright State University Boonshoft School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 18, 2015

Study Start

May 1, 2015

Primary Completion

December 19, 2018

Study Completion

December 19, 2018

Last Updated

July 28, 2022

Record last verified: 2022-07