Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, 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.
Interventions
DEVICEDEB-TACE with Surefire Precision Infusion System
Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.
Sponsors
Surefire Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumor response | 6 months following initial DEB-TACE procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | DEB-TACE procedure(s) | Number of lesions, location of lesions (uni-lobar versus bi-lobar), and distribution (unifocal, multi-focal, diffuse) |
Countries
United States
Outcome results
None listed