Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
This study is not yet open for participant recruitment.
Verified August 2012 by St. Joseph's Healthcare Hamilton
Sponsor:
St. Joseph's Healthcare Hamilton
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: August 23, 2012
Last verified: August 2012
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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 |
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 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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 | Not yet 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: | August 23, 2012 |
| 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 Neoplasms |
Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013