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| ID | Type | Description | Link |
|---|---|---|---|
| 000536794 | Other Grant/Funding Number | Varian Medical Systems |
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| Name | Class |
|---|---|
| Varian, a Siemens Healthineers Company | INDUSTRY |
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Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCC Participants | Experimental | Receive Trans-arterial embolization (TAE) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-arterial embolization (TAE) | Procedure | Trans-arterial embolization (TAE) is a minimally-invasive procedure in which the tumor-feeding arteries are catheterized under x-ray guidance and therapeutically occluded. TAE of the kidney is routinely performed in clinical practice for traumatic or iatrogenic injury or to de-vascularize tumors such as angiomyolipomas, oncocytomas, and RCC. The procedure has a long clinical history of success with a very low major complication rate. TAE of RCC with or without percutaneous cryoablation (PA) has been described in retrospective case series as a mechanism to destroy the tumor, reduce bleeding complications from PA, or improve symptoms of RCC such as pain or hematuria. However, these findings have yet to be confirmed in a rigorous, prospective fashion. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines. | 30-90days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Gunn, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Stanford Cancer Institute |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| Stanford |
| California |
| 94305 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Thomas Jefferson Health | Philadelphia | Pennsylvania | 19107 | United States |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |