Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts|
- concordance between CEUS and CT [ Time Frame: (Baseline, follow up at 3, 6, 9, & 12 months) ] [ Designated as safety issue: No ]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).
- histopathological diagnosis after surgery of complex renal cysts [ Time Frame: Baseline and every three months until the end of study. ] [ Designated as safety issue: Yes ]
- Average percent difference of CEUS vs CT imaging [ Time Frame: Baseline imaging (CEUS 14 days within a CT scan) ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Contrast-enhanced ultrasound||
Procedure: Contrast-enhanced ultrasound
A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.
Other Name: CEUS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353521
|Contact: Anil Kapoor, MD, FRCSC||(905) firstname.lastname@example.org|
|Contact: Camilla Tajzler||(905) 522-1155 ext email@example.com|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator: Anil Kapoor, MD|
|Principal Investigator:||Anil Kapoor, MD||McMaster Institute of Urology - St. Joseph's Healthcare Hamilton|
|Study Chair:||Christopher Allard, MD||McMaster Institute of Urology - St. Joseph's Healthcare Hamilton|