NCT03345225

Brief Summary

The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

November 13, 2017

Last Update Submit

September 7, 2018

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

Chemoembolization (TACE)HCCLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter

    The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage.

    1 month

Secondary Outcomes (12)

  • The Lencioni Score (LS)

    3 months

  • The Lencioni Score (LS)

    6 months

  • Objective Response Rate as measured by mRECIST

    1 Month

  • Objective Response Rate as measured by mRECIST

    3 Month

  • Objective Response Rate as measured by mRECIST

    6 Month

  • +7 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter

Device: Standard Endhole Microcatheter

Surefire Group

EXPERIMENTAL

Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System

Device: SureFire Infusion System

Interventions

SureFire Infusion SystemDEVICE

Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.

Surefire Group
Standard Endhole MicrocatheterDEVICE

A Microcatheter with a single hole at the end for a infusion.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Patients \> 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
  • Barcelona Clinic Liver Cancer Classification (BCLC) A or B
  • Child-Pugh Class A or B
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • to 5 target tumors that are \< 6cm with at least one tumor ≥ 3cm in size
  • Vessel size ≥ 1.5 mm
  • Subject must be able to provide written informed consent

You may not qualify if:

  • Extra-hepatic spread of the cancer
  • Macrovascular tumor invasion
  • Diffuse HCC (\>50% liver involvement)
  • Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
  • Advanced liver disease (bilirubin \> 3 mg/dl, aspartate aminotransferase (AST) or ALT \> 5x upper limit of normal or \> 250 U/I
  • Extrahepatic supply to the tumor
  • Hypovascular tumors
  • Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
  • Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Shree Venkat, MD

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Interventional Radiology

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

May 1, 2018

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)