Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Not Applicable

• Conditions: Complex Renal Cyst
• Interventions: Procedure: Contrast-enhanced ultrasound

• Registration Number: NCT01353521
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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 Description

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.

Study Timeline

• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-13
• Study Start: 2013-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-16
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast-enhanced ultrasound	Contrast-enhanced ultrasound	-

Primary Outcome Measures

Name	Time	Method
concordance between CEUS and CT	(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).

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada