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| ID | Type | Description | Link |
|---|---|---|---|
| 853163 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| TriSalus Life Sciences, Inc. | INDUSTRY |
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The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.
• Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?
Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.
Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End Hole Catheter followed by TriNav Catheter | Experimental | FDA approved catheter Randomization End Hole catheter then TriNav catheter |
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| TriNav Catheter followed by End Hole Catheter | Experimental | FDA approved catheter Randomization TriNav catheter then End Hold catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE Catheters | Device | End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure. This study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure |
| Measure | Description | Time Frame |
|---|---|---|
| volume and density of lipiodol | To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors | immediately following TACE |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Exploratory
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| University of Pennsylvania, Department of Radiology, Interventional Radiology Division |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |