- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01353521
Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
December 14, 2021 updated by: Anil Kapoor, St. Joseph's Healthcare Hamilton
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anil Kapoor, MD, FRCSC
- Phone Number: (905) 522-6536
- Email: akapoor@mcmaster.ca
Study Contact Backup
- Name: Marylrose Gundayao
- Phone Number: 35812 (905) 522-1155
- Email: mgundaya@stjosham.on.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- Recruiting
- St. Joseph's Healthcare Hamilton
-
Principal Investigator:
- Anil Kapoor, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contrast-enhanced ultrasound
|
A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
(Baseline, follow up at 3, 6, 9, & 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
histopathological diagnosis after surgery of complex renal cysts
Time Frame: Baseline and every three months until the end of study.
|
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.
|
Baseline imaging (CEUS 14 days within a CT scan)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2013
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
March 11, 2011
First Submitted That Met QC Criteria
May 12, 2011
First Posted (Estimate)
May 13, 2011
Study Record Updates
Last Update Posted (Actual)
December 16, 2021
Last Update Submitted That Met QC Criteria
December 14, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEUSEVCRC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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