Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Details

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.

Keywords

Hepatocellular Carcinoma DEB-TACE Carcinoma, Hepatocellular DEB-TACE with Surefire Precision Infusion System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSD in progress, not accepting new patients
    San Diego California United States
  • UCLA accepting new patients
    Los Angeles California United States
  • UCLA accepting new patients
    Los Angeles California United States
  • USC accepting new patients
    Los Angeles California United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Surefire Medical, Inc.
ID
NCT02967523
Study Type
Observational [Patient Registry]
Last Updated
November 17, 2017