Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
Primary Purpose
Complex Renal Cyst
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Contrast-enhanced ultrasound
Sponsored by

About this trial
This is an interventional diagnostic trial for Complex Renal Cyst focused on measuring complex renal cysts, Contrast enhanced ultrasound
Eligibility Criteria
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)
Sites / Locations
- St. Joseph's Healthcare HamiltonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast-enhanced ultrasound
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
histopathological diagnosis after surgery of complex renal cysts
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.
Full Information
NCT ID
NCT01353521
First Posted
March 11, 2011
Last Updated
December 14, 2021
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT01353521
Brief Title
Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
Official Title
Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2013 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Renal Cyst
Keywords
complex renal cysts, Contrast enhanced ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contrast-enhanced ultrasound
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Contrast-enhanced ultrasound
Other Intervention Name(s)
CEUS
Intervention Description
A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.
Primary Outcome Measure Information:
Title
concordance between CEUS and CT
Description
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).
Time Frame
(Baseline, follow up at 3, 6, 9, & 12 months)
Secondary Outcome Measure Information:
Title
histopathological diagnosis after surgery of complex renal cysts
Time Frame
Baseline and every three months until the end of study.
Title
Average percent difference of CEUS vs CT imaging
Description
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.
Time Frame
Baseline imaging (CEUS 14 days within a CT scan)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anil Kapoor, MD, FRCSC
Phone
(905) 522-6536
Email
akapoor@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marylrose Gundayao
Phone
(905) 522-1155
Ext
35812
Email
mgundaya@stjosham.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Kapoor, MD
Organizational Affiliation
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Allard, MD
Organizational Affiliation
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anil Kapoor, MD
12. IPD Sharing Statement
Learn more about this trial
Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
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