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Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

This study is currently recruiting participants.
Verified April 2017 by Anil Kapoor, St. Joseph's Healthcare Hamilton
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353521
First Posted: May 13, 2011
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
McMaster University
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
  Purpose
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.

Condition Intervention
Complex Renal Cyst Procedure: Contrast-enhanced ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Resource links provided by NLM:


Further study details as provided by Anil Kapoor, St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • histopathological diagnosis after surgery of complex renal cysts [ Time Frame: 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.


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contrast-enhanced ultrasound Procedure: Contrast-enhanced ultrasound
A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.
Other Name: CEUS

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353521


Contacts
Contact: Anil Kapoor, MD, FRCSC (905) 522-6536 akapoor@mcmaster.ca
Contact: Camilla Tajzler (905) 522-1155 ext 35876 tajzlec@mcmaster.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Anil Kapoor, MD         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
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
  More Information

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01353521     History of Changes
Other Study ID Numbers: CEUSEVCRC
First Submitted: March 11, 2011
First Posted: May 13, 2011
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Anil Kapoor, St. Joseph's Healthcare Hamilton:
complex renal cysts
Contrast enhanced ultrasound

Additional relevant MeSH terms:
Cysts
Kidney Diseases, Cystic
Neoplasms
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases