Surefire Precision Infusion System Registry
Status: | Terminated |
---|---|
Conditions: | Liver Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/13/2018 |
Start Date: | May 2016 |
End Date: | June 18, 2018 |
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.
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.
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.
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.
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
We found this trial at
10
sites
1700 S Tamiami Trail
Sarasota, Florida 34239
Sarasota, Florida 34239
(941) 917-9000
Principal Investigator: Justin Lee, MD
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Ryan O'Hara, MD
University of Utah Research is a major component in the life of the U benefiting...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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11100 Euclid Ave
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Jon Davidson, MD
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Balijendra Kapoor, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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601 E Rollins St
Orlando, Florida 32803
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Francisco Contreras, MD
Florida Hospital Florida Hospital is one of the country
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Washington, District of Columbia 20007
Principal Investigator: Alexander Kim, MD
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