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Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01353521
Enrollment
40
Registered
2011-05-13
Start date
2013-12-31
Completion date
2022-12-31
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Renal Cyst

Keywords

complex renal cysts, Contrast enhanced ultrasound

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.

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.

Interventions

PROCEDUREContrast-enhanced ultrasound

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

Sponsors

McMaster University
CollaboratorOTHER
St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
concordance between CEUS and CT(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

MeasureTime frameDescription
histopathological diagnosis after surgery of complex renal cystsBaseline and every three months until the end of study.
Average percent difference of CEUS vs CT imagingBaseline 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.

Countries

Canada

Contacts

Primary ContactAnil Kapoor, MD, FRCSC
akapoor@mcmaster.ca(905) 522-6536
Backup ContactMarylrose Gundayao
mgundaya@stjosham.on.ca(905) 522-1155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026