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

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

Study Contact Backup

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:
  • CEUS

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.

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

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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