Surefire Institutional DEB-TACE

January 21, 2020 updated by: Alexander Kim

Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)

The purpose of this study is to determine the feasibility and safety of the Surefire Infusion System (SIS) for delivery of Drug Eluting Beads Transcatheter Chemoembolization (DEB-TACE) in the HCC population. This study will allow us to determine the effectiveness of SIS for HCC in terms of disease response.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a single arm pilot study to evaluate the technical feasibility and safety of performing DEB-TACE using the investigational delivery device: Surefire Infusion System (SIS). Patients presenting with primary liver cancer without evidence of metastatic disease or vascular invasion will be considered for the trial. Patients enrolled in the trial will undergo 1 or 2 sessions of DEB-TACE delivered through SIS as determined by the performing interventional radiologist. Decision for second treatment will be based on the degree of disease burden and vascular anatomy demonstrated on the first treatment session. To limit potential hepatotoxicity, patients with multifocal disease in a single lobe may be treated with a 2nd treatment with the investigational device. Patients with a large lesion being supplied by multiple vessels may also undergo a 2nd treatment session based on the investigator's judgement. The decision to proceed with a second treatment will be determined at the time of the first treatment based on disease burden and vascular anatomy. There will be an interval of 2-4 weeks between treatments. All patients undergoing 2nd treatment will have a repeat laboratory evaluation with treatment deferred for 2-4 weeks for those not meeting initial inclusion criteria. For patients who labs have not normalized at this time will not undergo a 2nd treatment.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary liver cancers based on biopsy or imaging criteria
  2. Child-Pugh A or B7 liver disease
  3. Bilirubin <2.0 mg/dL
  4. Albumin >3.0 gm/dL
  5. ECOG status 0 or 1

  6. Adequate renal function

    a. Creatinine < 2.0 mg/dL

  7. Age 18 or older
  8. Able to understand informed consent
  9. Life expectancy > 3 months
  10. Women of childbearing potential must have a negative serum/urine pregnancy test on the day of planned procedure.

Exclusion Criteria:

  1. Portal vein thrombus
  2. Uncontrolled ascites
  3. Hepatic encephalopathy
  4. Uncorrectable coagulopathy (platelets <50,000, INR >1.50)
  5. Untreatable contrast allergy
  6. Pregnancy
  7. Symptomatic congestive heart failure
  8. Prior systematic therapy for HCC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TACE with Surefire
Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System.
Procedure: TACE with Surefire
Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stasis of flow in target vessel as seen on digital subtraction angiography or cone-beam CT, or reflux of particles despite the use of SIS.
Time Frame: During chemoembolization
Assess the technical feasibility of performing TACE using the SIS. If stasis of flow is not reached after 1 vial of DEB, further bland embolization will be performed until stasis is reached or earlier as determined adequate by the treating interventional radiologist.
During chemoembolization
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Duration of study (12 months)
Assess the safety of SIS for TACE as per CTCAE v 4.03
Duration of study (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Assessment via MRI Imaging
Time Frame: Duration of study (12 months)
Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria
Duration of study (12 months)
Tumor Assessment via CT Imaging
Time Frame: Duration of study (12 months)
Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria
Duration of study (12 months)
FACT Hep4 Questionnaire
Time Frame: Visit 5 (week 5)
Correlate outcomes with treatment endpoint, defined as stasis of flow in target vessel on DSA or CBCT, or reflux of particles despite the use of SIS
Visit 5 (week 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexander Kim

Collaborators

Surefire Medical, Inc.

Investigators

  • Principal Investigator: Alexander Y Kim, MD, MedStar Georgetown University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF Georgetown

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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