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| Name | Class |
|---|---|
| McMaster University | OTHER |
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Complex renal cysts are often incidentally detected on imaging. The differential diagnosis of the complex renal cyst includes various benign cystic lesions, which are based on the Bosniak classification scheme. Currently the standard of care in evaluating a complex renal cyst is using a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan. Since both of these modalities present adverse events due to frequent high doses of radiation, a technique such as a contrast-enhanced ultrasound (CEUS) can be used to obtain the same results, without having to impose high doses of radiation upon a patient.
By evaluating complex renal cysts using a contrast-enhanced ultrasound (CEUS), it can be established as to whether or not the results are better, the same, or worse, when compared to CT and/or MRI scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast-enhanced ultrasound | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced ultrasound | Procedure | A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| concordance between CEUS and CT | Complex renal cysts will be classified using the Bosniak classification system for both the CEUS and CT and compared. If surgical removal of a complex cyst is required (Bosniak IIF, III or IV), then the pathology will be evaluated with a single CEUS and a CT (The CEUS will be conducted 14 days within the CT). | (Baseline, follow up at 3, 6, 9, & 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| histopathological diagnosis after surgery of complex renal cysts | Baseline and every three months until the end of study. | |
| Average percent difference of CEUS vs CT imaging | If during watchful waiting another CEUS is needed to be done in cases where a CT scan does show change at a follow up visit, then this average percent difference will also be calculated at this point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anil Kapoor, MD, FRCSC | Contact | (905) 522-6536 | akapoor@mcmaster.ca | |
| Marylrose Gundayao | Contact | (905) 522-1155 | 35812 | mgundaya@stjosham.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anil Kapoor, MD | McMaster Institute of Urology - St. Joseph's Healthcare Hamilton | Principal Investigator |
| Christopher Allard, MD | McMaster Institute of Urology - St. Joseph's Healthcare Hamilton | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
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| Baseline imaging (CEUS 14 days within a CT scan) |