Surefire Precision Infusion System Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surefire Precision Infusion System Registry

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: DEB-TACE with Surefire Precision Infusion System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DEB-TACE with Surefire Precision Infusion System|Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response |  | 6 months following initial DEB-TACE procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response |  | 1 and 3 months following initial DEB-TACE procedure | 
| Dose of doxorubicin-eluting beads used during DEB-TACE procedure(s) |  | 6 months following initial DEB-TACE procedure | 
| Tumor characteristics | Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse) | DEB-TACE procedure(s) | 
| Size of doxorubicin-eluting beads used during DEB-TACE procedure(s) |  | DEB-TACE procedure(s) | 
| Changes in alpha-fetoprotein (AFP) blood levels |  | 1, 3 and 6 months following initial DEB-TACE procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, DEB-TACE