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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB-TACE with Surefire Precision Infusion System | Device | Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response | 6 months following initial DEB-TACE procedure. |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been diagnosed with HCC in which the Surefire Precision Infusion System was used/will be used to deliver DEB-TACE.
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| Name | Affiliation | Role |
|---|---|---|
| Baljendra Kapoor, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | United States | |||
| USC |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| Los Angeles |
| California |
| United States |
| UCSD | San Diego | California | United States |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | United States |
| Florida Hospital | Orlando | Florida | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | United States |
| University of Maryland Medical Center | Baltimore | Maryland | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | United States |
| University of Utah | Salt Lake City | Utah | United States |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |