Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

NCT ID: NCT01353521

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Complex Renal Cyst

Keywords

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complex renal cysts Contrast enhanced ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contrast-enhanced ultrasound

Group Type EXPERIMENTAL

Contrast-enhanced ultrasound

Intervention Type PROCEDURE

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

Interventions

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Contrast-enhanced ultrasound

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

Intervention Type PROCEDURE

Other Intervention Names

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CEUS

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Anil Kapoor

MD, FRCSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anil Kapoor, MD

Role: PRINCIPAL_INVESTIGATOR

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

Christopher Allard, MD

Role: STUDY_CHAIR

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

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anil Kapoor, MD, FRCSC

Role: CONTACT

Phone: (905) 522-6536

Email: [email protected]

Marylrose Gundayao

Role: CONTACT

Phone: (905) 522-1155

Email: [email protected]

Other Identifiers

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CEUSEVCRC

Identifier Type: -

Identifier Source: org_study_id