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Surefire Institutional DEB-TACE

Sponsor
Alexander Kim (Other)
Overall Status
Unknown status
CT.gov ID
NCT03211598
Collaborator
Surefire Medical, Inc. (Industry)
15
Enrollment
1
Location
1
Arm
42
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TACE with Surefire
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Trial Assessing the Technical Feasibility and Safety of the Surefire Infusion System for Use in DEB-TACE (Surefire)
Actual Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Duration of study (12 months)]

    Assess the safety of SIS for TACE as per CTCAE v 4.03

Secondary Outcome Measures

  1. Tumor Assessment via MRI Imaging [Duration of study (12 months)]

    Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria

  2. Tumor Assessment via CT Imaging [Duration of study (12 months)]

    Assess the disease response rates of HCC with TACE using the SIS per mRECIST criteria

  3. FACT Hep4 Questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Creatinine < 2.0 mg/dL

  1. Age 18 or older

  2. Able to understand informed consent

  3. Life expectancy > 3 months

  4. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medstar Georgetown University Hospital Washington District of Columbia United States 20007

Sponsors and Collaborators

  • Alexander Kim
  • Surefire Medical, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alexander Kim, Chief of Interventional Radiology at Medstar Georgetown University Hospital, Georgetown University
ClinicalTrials.gov Identifier:
NCT03211598
Other Study ID Numbers:
  • SF Georgetown
First Posted:
Jul 7, 2017
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jan 22, 2020