Surefire Institutional DEB-TACE

NCT ID: NCT03211598

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-04-30

Brief Summary

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.

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TACE with Surefire

Subjects enrolled in the study will have their TACE procedure with the Surefire Infusion System.

Group Type: OTHER

TACE with Surefire

Intervention Type: PROCEDURE

Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System

Interventions

TACE with Surefire

Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surefire Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Alexander Kim

OTHER

Sponsor Role: lead

Responsible Party

Alexander Kim

Chief of Interventional Radiology at Medstar Georgetown University Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexander Y Kim, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Georgetown University Hospital

Locations

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

References

Lee KK, Kim DG, Moon IS, Lee MD, Park JH. Liver transplantation versus liver resection for the treatment of hepatocellular carcinoma. J Surg Oncol. 2010 Jan 1;101(1):47-53. doi: 10.1002/jso.21415.

Reference Type: BACKGROUND

PMID: 19798686 (View on PubMed)

Other Identifiers

SF Georgetown

Identifier Type: -

Identifier Source: org_study_id