ClinicalTrials.gg
Status unknownNCT01353521Updated Dec 16, 2021

Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts

An interventional study of Contrast-enhanced ultrasound in Complex Renal Cyst, sponsored by St. Joseph's Healthcare Hamilton. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Complex Renal Cyst

Keywords

  • complex renal cysts
  • Contrast enhanced ultrasound
03

In context

Lead sponsor

St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnant patients
  • patients with contrast allergies
  • patients with non-cystic, solid renal masses
  • patients with simple cysts (Bosniak class I and II)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Contrast-enhanced ultrasound

    Procedure: Contrast-enhanced ultrasound

Interventions

  • ProcedureContrast-enhanced ultrasound

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

    Also known as: CEUS

06

What researchers measure

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).

    Time frame: (Baseline, follow up at 3, 6, 9, & 12 months)

Secondary outcomes

  1. histopathological diagnosis after surgery of complex renal cysts

    Time frame: Baseline and every three months until the end of study.

  2. 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.

    Time frame: Baseline imaging (CEUS 14 days within a CT scan)

07

Study locations

1 of 1 sites recruiting
  • St. Joseph's Healthcare Hamilton
    Hamilton, Ontario L8N 4A6, Canada
    • Anil Kapoor, MD · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2013 (actual). Primary completion is estimated for Dec 2022, 108 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2011
First posted
May 13, 2011
StartActual
Dec 2013
Primary completionEst.
Dec 2022
CompletionEst.
Dec 2022
Last update
Dec 16, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01353521
Collaborators
McMaster University
Responsible party
Anil Kapoor (MD, FRCSC, St. Joseph's Healthcare Hamilton) — Principal investigator
First posted
May 13, 2011
Start date
Dec 2013
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Dec 16, 2021

Study contacts

Anil Kapoor, MD, FRCSC
Contact
akapoor@mcmaster.ca
(905) 522-6536
Marylrose Gundayao
Contact
mgundaya@stjosham.on.ca
(905) 522-1155 ext. 35812
Anil Kapoor, MD
principal investigator · McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Christopher Allard, MD
study chair · McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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