Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Complex Renal Cyst Clinical Trial

Official title:

Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01353521
• Other study ID #: CEUSEVCRC
• Status: Recruiting
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: Anil Kapoor, MD, FRCSC
• Phone: (905) 522-6536
• Email: akapoor[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Complex Renal Cyst
• Cysts

Intervention

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

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	histopathological diagnosis after surgery of complex renal cysts		Baseline and every three months until the end of study.
Secondary	Average percent difference of CEUS vs CT imaging	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.	Baseline imaging (CEUS 14 days within a CT scan)