Recruiting

Observational Study

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT01353521

Conditions

Complex Renal Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Contrast-enhanced ultrasound

Study Details

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

Study ID

NCT01353521

Start date

Dec, 2013

Status verified date

Dec, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Contrast-enhanced ultrasound

Interventions

Contrast-enhanced ultrasound

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

Primary outcome measure

  • concordance between CEUS and CT [ Time Frame: (Baseline, follow up at 3, 6, 9, & 12 months) ]

Central Contacts and Locations

Central contacts

Anil Kapoor, MD, FRCSC

(905) 522-6536akapoor@mcmaster.ca

Marylrose Gundayao

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

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Principal Investigator:

Anil Kapoor, MD

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Dec 16, 2021

Last verified

Dec, 2021

Keywords

  • complex renal cysts
  • Contrast enhanced ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2021-12-16.