Clinical trial NCT03211598: Surefire Institutional DEB-TACE
Official title: Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Surefire Medical, Inc.
First posted: 2017-07-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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.
timeFrame: During chemoembolization
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Duration of study (12 months)
Secondary outcomes:
measure: Tumor Assessment via MRI Imaging
timeFrame: Duration of study (12 months)
measure: Tumor Assessment via CT Imaging
timeFrame: Duration of study (12 months)
measure: FACT Hep4 Questionnaire
timeFrame: Visit 5 (week 5)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Alexander Y Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.