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Trial Title:
Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
NCT ID:
NCT01353521
Condition:
Complex Renal Cyst
Conditions: Official terms:
Cysts
Kidney Diseases, Cystic
Conditions: Keywords:
complex renal cysts
Contrast enhanced ultrasound
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Contrast-enhanced ultrasound
Description:
A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance
visualization in real time.
Arm group label:
Contrast-enhanced ultrasound
Other name:
CEUS
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Joseph's Healthcare Hamilton
Address:
City:
Hamilton
Zip:
L8N 4A6
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Anil Kapoor, MD
Email:
Principal Investigator
Start date:
December 2013
Completion date:
December 2022
Lead sponsor:
Agency:
St. Joseph's Healthcare Hamilton
Agency class:
Other
Collaborator:
Agency:
McMaster University
Agency class:
Other
Source:
St. Joseph's Healthcare Hamilton
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01353521
