Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
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|ClinicalTrials.gov Identifier: NCT01353521|
Recruitment Status : Recruiting
First Posted : May 13, 2011
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Complex Renal Cyst||Procedure: Contrast-enhanced ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||August 2018|
|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
- concordance between CEUS and CT [ Time Frame: (Baseline, follow up at 3, 6, 9, & 12 months) ]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. ]
- Average percent difference of CEUS vs CT imaging [ Time Frame: Baseline imaging (CEUS 14 days within a CT scan) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|