search
Back to results

Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE (SPEED)

Primary Purpose

Hepatocellular Carcinoma of the Liver, Subjects Eligible for Liver Transplantation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surefire Precision Infusion System
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma of the Liver

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation and considered for downstaging.
  • Patients undergoing Surefire DEB-TACE procedure as clinically determined
  • Single tumor that is >5 cm and less than 8 cm, OR 1 to 3 tumors with combined diameter greater than 15 cm and less than 24 cm
  • No portal invasion or extrahepatic spread
  • No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Preserved liver function (Child-Pugh Class A or B).
  • Discrete hepatic artery feeding the tumor with vessel diameter > 1.5 mm

Exclusion Criteria:

  • Advanced bilirubin levels > 3 mg/dl
  • AST or ALT>5 upper limit of normal or >250 U/l
  • Advanced tumoral disease, defined as vascular invasion, extrahepatic spread, or diffuse HCC (50% liver involvement)
  • Contraindications for doxorubicin administration.
  • Child's Class C
  • Vessels providing flow to the tumor that are less than 1.5 mm in diameter

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DEB-TACE Procedure with Surefire Precision Infusion System

Arm Description

The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.

Outcomes

Primary Outcome Measures

Local Recurrence Rate (LRR)
For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test.

Secondary Outcome Measures

Tumor Response
For the outcome of tumor response measured as the change in enhancing tumor size (pretreatment - post treatment) we will evaluate changes at 1 month and 6 month separately.
Time to Progression
For the outcome of time to progression, we will quantify the number of weeks from treatment until tumor progression.
Survival Time
For the outcome of survival time, we will quantify the number of weeks from treatment until death.

Full Information

First Posted
May 26, 2017
Last Updated
December 14, 2021
Sponsor
University of Colorado, Denver
Collaborators
Surefire Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03170869
Brief Title
Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE
Acronym
SPEED
Official Title
SPEED 1 Trial: Bridge to Orthotopic Liver Transplantation (OLT) - (Surefire Precision vs Endhole Embolization With DEBTACE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew funding
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
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 study will be to prospectively evaluate the outcomes of patients with hepatocellular carcinoma (HCC) who undergo DEB-TACE (drug-eluting bead trans-arterial chemoembolization) with the Surefire Precision Infusion System for intentional effect of down-staging patients to OLT. Patients with HCC and who are considered candidates for liver transplantation but outside Milancriteria and meet the eligibility criteria will be enrolled in the prospective single arm study. Results of the prospective cohort will be compared to matched historical control patients who were previously treated with DEB-TACE, delivered with standard endhole catheters. This includes all patients treated at the University of Colorado since 2009 treated with 100-300 micron beads for whom follow-up is available.
Detailed Description
This is a single institution prospective clinical trial with historical matched controls. This protocol standardizes DEB-TACE delivery with the Surefire Precision Infusion System. This protocol does not change patient therapy. All patient safety monitoring, treatment procedures and follow-up procedures will be performed in accordance with standard clinical practice. Fifty (50) subjects will be enrolled in the prospective arm. Data from one hundred (100) historical randomly sampled control subjects (1:2 ratio) will be selected. Subjects will be followed at 1 week, 1 month, 3 months, then every 3 months, following the initial DEB-TACE procedure until the subject receives a liver transplant or death. The study will be concluded upon completion of enrollment and follow-up of the 50 patients. It is estimated that the time to complete patient enrollment and follow-up is 24 months. The estimated date for study completion (complete primary analyses) is June 2018. This is based on the average survival vs. time to transplant at this center. If there are individual patients that extend beyond this period the time may be slightly extended.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma of the Liver, Subjects Eligible for Liver Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Fifty (50) subjects will be enrolled in the prospective arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEB-TACE Procedure with Surefire Precision Infusion System
Arm Type
Experimental
Arm Description
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.
Intervention Type
Device
Intervention Name(s)
Surefire Precision Infusion System
Intervention Description
All patients enrolled in this protocol will receive DEB-TACE, which is the standard of care prescribed by their physician. Standard 5 Fr and 3 Fr catheters will be used to perform diagnostic angiography to map the hepatic vasculature to the tumor. Using standard technique, the target vessel feeding the tumor will be catheterized and DEB-TACE administered using the Surefire Precision catheter. The Doxorubicin dosing used in the DEB-TACE will be based upon tumor volume. DEB-TACE will be administered until the first of the following endpoints are reached: Achievement of target dose with stasis, leeching of contrast through the expandable tip and development of distal intrahepatic collaterals.
Primary Outcome Measure Information:
Title
Local Recurrence Rate (LRR)
Description
For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tumor Response
Description
For the outcome of tumor response measured as the change in enhancing tumor size (pretreatment - post treatment) we will evaluate changes at 1 month and 6 month separately.
Time Frame
6 months
Title
Time to Progression
Description
For the outcome of time to progression, we will quantify the number of weeks from treatment until tumor progression.
Time Frame
Every 3 months through 24 months
Title
Survival Time
Description
For the outcome of survival time, we will quantify the number of weeks from treatment until death.
Time Frame
Every 3 months through 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation and considered for downstaging. Patients undergoing Surefire DEB-TACE procedure as clinically determined Single tumor that is >5 cm and less than 8 cm, OR 1 to 3 tumors with combined diameter greater than 15 cm and less than 24 cm No portal invasion or extrahepatic spread No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Preserved liver function (Child-Pugh Class A or B). Discrete hepatic artery feeding the tumor with vessel diameter > 1.5 mm Exclusion Criteria: Advanced bilirubin levels > 3 mg/dl AST or ALT>5 upper limit of normal or >250 U/l Advanced tumoral disease, defined as vascular invasion, extrahepatic spread, or diffuse HCC (50% liver involvement) Contraindications for doxorubicin administration. Child's Class C Vessels providing flow to the tumor that are less than 1.5 mm in diameter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T Johnson, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE

We'll reach out to this number within 24 hrs