Clinical Trial: Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: St. Joseph's Healthcare Hamilton

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: St. Joseph's Healthcare Hamilton

Dates:
Date Received: March 11, 2011
Date Started: December 2013
Date Completion: August 2017
Last Updated: April 4, 2017
Last Verified: April 2017