Clinical trial NCT02967523: Surefire Precision Infusion System Registry
Official title: Surefire Precision Infusion System Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
DEB-TACE
Lead sponsor: SurefireMedical
Sponsor class: UNKNOWN
First posted: 2016-11-18
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with HCC in which the Surefire Precision Infusion System was used/will be used to deliver DEB-TACE.

Brief summary: This project involves the collection and analysis of retrospective and prospective data on patients diagnosed with hepatocellular carcinoma (HCC) in which the Surefire Precision Infusion System was used/will used be to deliver transarterial chemoembolization with doxorubicin-eluting beads (DEB-TACE). The purpose is to compare tumor and medical response in a real-world setting as well as identify potential areas for future clinical research.

Detailed description: Conventional transarterial chemoembolization with lipiodol/doxorubicin (cTACE) is known to prolong survival compared to supportive therapy in certain patients with unresectable HCC, including patients with unilateral portal vein invasion (PVI). The best results for cTACE occur when the dose is delivered in a highly targeted manner into the tumor. Dense accumulation of embolic spheres or lipiodol into the tumor as documented by computed tomography (CT) has been shown to have improved outcomes. However, with standard endhole catheters, achieving maximum delivery of embolic agents is significantly limited by the development of stasis, non-target delivery and subsequent non-target injury. Thus, when this procedure is performed with endhole catheters, there is significant variability in the delivery of the agent that is entirely dependent on the flow pattern of the target tumor. Therefore, current techniques result in various degrees of embolization with variability in dosages and angiographic endpoints.

DEB-TACE is a relatively new modality associated with favorable systemic doxorubicin exposure/toxicity and liver-specific toxicity compared to cTACE. It is currently utilized for: (1) patients who have unresectable HCC; (2) patients who meet the Milan Criteria and are currently on liver transplantation lists; and (3) downstaging patients into Milan Criteria for possible liver transplantation.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone or will undergo DEB-TACE for HCC delivered by the Surefire® Precision Infusion System
* Patients aged 18 years or older
* Diagnosis of HCC
* Has a discrete hepatic artery(s) feeding the vessel with diameter(s) of the vessels ≥ 1.5 mm

Exclusion Criteria:

* Contraindications for doxorubicin administration
* Vessels providing flow to the tumor that are \< 1.5 mm in diameter(s)
* Patients who are unable to provide informed consent

Primary outcomes:
measure: Objective tumor response
timeFrame: 6 months following initial DEB-TACE procedure.
Secondary outcomes:
measure: Objective tumor response
timeFrame: 1 and 3 months following initial DEB-TACE procedure
measure: Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s)
timeFrame: 6 months following initial DEB-TACE procedure
measure: Tumor characteristics
timeFrame: DEB-TACE procedure(s)
measure: Size of doxorubicin-eluting beads used during DEB-TACE procedure(s)
timeFrame: DEB-TACE procedure(s)
measure: Changes in alpha-fetoprotein (AFP) blood levels
timeFrame: 1, 3 and 6 months following initial DEB-TACE procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: USC
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: The Cleveland Clinic
name: Baljendra Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References: