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Funding
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| Name | Class |
|---|---|
| Surefire Medical, Inc. | INDUSTRY |
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The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter |
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| Surefire Group | Experimental | Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SureFire Infusion System | Device | Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter | The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The Lencioni Score (LS) | The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage. | 3 months |
| The Lencioni Score (LS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shree Venkat, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Standard Endhole Microcatheter | Device | A Microcatheter with a single hole at the end for a infusion. |
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The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage. |
| 6 months |
| Objective Response Rate as measured by mRECIST | Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions | 1 Month |
| Objective Response Rate as measured by mRECIST | Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions | 3 Month |
| Objective Response Rate as measured by mRECIST | Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions | 6 Month |
| Distribution of Radiopaque beads | Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms | 1 Month |
| Distribution of Radiopaque beads | Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms | 3 Month |
| Distribution of Radiopaque beads | Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms | 6 Month |
| Tumor enhancement | Comparing tumor enhancement relative to a calibrated imaging phantom | 1 month |
| Tumor enhancement | Comparing tumor enhancement relative to a calibrated imaging phantom | 3 month |
| Tumor enhancement | Comparing tumor enhancement relative to a calibrated imaging phantom | 6 month |
| Number of Adverse Event | Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE) | 6 months |
| D008107 |
| Liver Diseases |