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A Clinical Study of Precision TACE (P-TACE) With Surefire

Primary Purpose

Unresectable Hepatocellular Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SureFire Infusion System
Standard Endhole Microcatheter
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Unresectable Hepatocellular Carcinoma focused on measuring Chemoembolization (TACE), HCC, Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Surefire Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Lencioni Score (LS)
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.
The Lencioni Score (LS)
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.
Objective Response Rate as measured by mRECIST
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Objective Response Rate as measured by mRECIST
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Objective Response Rate as measured by mRECIST
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Distribution of Radiopaque beads
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Distribution of Radiopaque beads
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Distribution of Radiopaque beads
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Tumor enhancement
Comparing tumor enhancement relative to a calibrated imaging phantom
Tumor enhancement
Comparing tumor enhancement relative to a calibrated imaging phantom
Tumor enhancement
Comparing tumor enhancement relative to a calibrated imaging phantom
Number of Adverse Event
Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE)

Full Information

First Posted
November 13, 2017
Last Updated
September 7, 2018
Sponsor
University of Miami
Collaborators
Surefire Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03345225
Brief Title
A Clinical Study of Precision TACE (P-TACE) With Surefire
Official Title
A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Surefire Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Hepatocellular Carcinoma
Keywords
Chemoembolization (TACE), HCC, Liver Cancer

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter
Arm Title
Surefire Group
Arm Type
Experimental
Arm Description
Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System
Intervention Type
Device
Intervention Name(s)
SureFire Infusion System
Intervention Description
Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
Intervention Type
Device
Intervention Name(s)
Standard Endhole Microcatheter
Intervention Description
A Microcatheter with a single hole at the end for a infusion.
Primary Outcome Measure Information:
Title
Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
The Lencioni Score (LS)
Description
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.
Time Frame
3 months
Title
The Lencioni Score (LS)
Description
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.
Time Frame
6 months
Title
Objective Response Rate as measured by mRECIST
Description
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Time Frame
1 Month
Title
Objective Response Rate as measured by mRECIST
Description
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Time Frame
3 Month
Title
Objective Response Rate as measured by mRECIST
Description
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Time Frame
6 Month
Title
Distribution of Radiopaque beads
Description
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Time Frame
1 Month
Title
Distribution of Radiopaque beads
Description
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Time Frame
3 Month
Title
Distribution of Radiopaque beads
Description
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Time Frame
6 Month
Title
Tumor enhancement
Description
Comparing tumor enhancement relative to a calibrated imaging phantom
Time Frame
1 month
Title
Tumor enhancement
Description
Comparing tumor enhancement relative to a calibrated imaging phantom
Time Frame
3 month
Title
Tumor enhancement
Description
Comparing tumor enhancement relative to a calibrated imaging phantom
Time Frame
6 month
Title
Number of Adverse Event
Description
Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shree Venkat, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Study of Precision TACE (P-TACE) With Surefire

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