Surefire Institutional DEB-TACE

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03211598
• Other study ID #: SF Georgetown
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 2020

Study information

• Verified date: January 2020
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• TACE with Surefire
Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System

Locations

Country	Name	City	State
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Alexander Kim	Surefire Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Assess the safety of SIS for TACE as per CTCAE v 4.03	Duration of study (12 months)
Secondary	Tumor Assessment via MRI Imaging	Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria	Duration of study (12 months)
Secondary	Tumor Assessment via CT Imaging	Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria	Duration of study (12 months)
Secondary	FACT Hep4 Questionnaire	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)