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Surefire Institutional DEB-TACE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211598
Recruitment Status : Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Surefire Medical, Inc.
Information provided by (Responsible Party):
Alexander Kim, Georgetown University

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
Hepatocellular Carcinoma Procedure: TACE with Surefire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
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




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. [ 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211598


Locations
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United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Alexander Kim
Surefire Medical, Inc.
Investigators
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Principal Investigator: Alexander Y Kim, MD MedStar Georgetown University Hospital
Publications:
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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: July 7, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases