Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01353521
First received: March 11, 2011
Last updated: July 14, 2014
Last verified: July 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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 St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • concordance between CEUS and CT [ Time Frame: (Baseline, follow up at 3, 6, 9, & 12 months) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
  • Average percent difference of CEUS vs CT imaging [ Time Frame: Baseline imaging (CEUS 14 days within a CT scan) ] [ Designated as safety issue: No ]
    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: April 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01353521     History of Changes
Other Study ID Numbers: CEUSEVCRC
Study First Received: March 11, 2011
Last Updated: July 14, 2014
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014