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Clinical Trials/NCT01353521
NCT01353521
Unknown
Not Applicable

Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

St. Joseph's Healthcare Hamilton1 site in 1 country40 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complex Renal Cyst
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
40
Locations
1
Primary Endpoint
concordance between CEUS and CT
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anil Kapoor

MD, FRCSC

St. Joseph's Healthcare Hamilton

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)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • 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))

Study Sites (1)

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