Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

NCT01353521 | Unknown

• 1 other identifier: CEUSEVCRC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Renal Cyst

Keywords

complex renal cysts; Contrast enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• concordance between CEUS and CT

  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 Outcomes (2)

• 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 Arms (1)

Contrast-enhanced ultrasound

EXPERIMENTAL

Procedure: Contrast-enhanced ultrasound

Interventions

Contrast-enhanced ultrasound PROCEDURE

A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.

Also known as: CEUS

Contrast-enhanced ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant patients
• patients with contrast allergies
• patients with non-cystic, solid renal masses
• patients with simple cysts (Bosniak class I and II)

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Study Officials

• Anil Kapoor, MD

  McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Christopher Allard, MD

  McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

  STUDY CHAIR

Central Study Contacts

Anil Kapoor, MD, FRCSC

CONTACT

(905) 522-6536; akapoor@mcmaster.ca

Marylrose Gundayao

CONTACT

(905) 522-1155; mgundaya@stjosham.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: May 13, 2011
• Study Start: December 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

CA (1)