Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Conditions
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Complex Renal Cyst

Intervention / Treatment
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* Procedure: Contrast-enhanced ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years old and capable of giving informed consent all patients undergoing CT evaluation of complex renal cysts at our centre (either initially or in follow-up) A complex renal cyst defined as Bosniak IIF, III or IV Exclusion Criteria: pregnant patients patients with contrast allergies patients with non-cystic, solid renal masses patients with simple cysts (Bosniak class I and II)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast-enhanced ultrasound<br> | Procedure: Contrast-enhanced ultrasound<br>* A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.<br>* Other names: CEUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline imaging (CEUS 14 days within a CT scan) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complex renal cysts, Contrast enhanced ultrasound