Complex Renal CystNCT01353521
Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
A study testing Contrast-enhanced ultrasound in people with Complex Renal Cyst, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Renal Cyst
- What is being tested?
- Contrast-enhanced ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant patients
- patients with contrast allergies
- patients with non-cystic, solid renal masses
- patients with simple cysts (Bosniak class I and II)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Anil Kapoor, MD
About this study
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.
- Conditions
- Complex Renal Cyst
- Being tested
- Contrast-enhanced ultrasound
- Keywords
- complex renal cysts, Contrast enhanced ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced ultrasoundProcedure or surgery
Also called CEUS
A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced ultrasound | Experimental | Not described Receives: Procedure: Contrast-enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: (Baseline, follow up at 3, 6, 9, & 12 months)
Secondary outcomes (2)
histopathological diagnosis after surgery of complex renal cysts
Measured: Baseline and every three months until the end of study.
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.
Measured: Baseline imaging (CEUS 14 days within a CT scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startDec 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Renal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Anil Kapoor, St. Joseph's Healthcare Hamilton
- Investigators
- Anil Kapoor, MD, Principal investigator, McMaster Institute of Urology - St. Joseph's Healthcare HamiltonChristopher Allard, MD, Study chair, McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353521
- Sponsor's protocol ID
- CEUSEVCRC
- Status last verified
- Dec 2021
- First submitted
- 11 Mar 2011
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
- ClinicalTrials.gov ID
- NCT01353521
- Acronym / sponsor ID
- CEUSEVCRC
- Conditions
- Complex Renal Cyst
- Keywords
- complex renal cysts, Contrast enhanced ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced ultrasound | Experimental | Procedure: Contrast-enhanced ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- pregnant patients
- patients with contrast allergies
- patients with non-cystic, solid renal masses
- patients with simple cysts (Bosniak class I and II)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced ultrasoundAlso: CEUSA contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time. | Procedure or surgery | Contrast-enhanced ultrasound |
Primary outcome
concordance between CEUS and CT
Time frame: (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).
2 secondary outcomes
histopathological diagnosis after surgery of complex renal cysts
Time frame: Baseline and every three months until the end of study.
Average percent difference of CEUS vs CT imaging
Time frame: Baseline imaging (CEUS 14 days within a CT scan)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced ultrasound in people with Complex Renal Cyst, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Kapoor, MD, FRCSC ((905) 522-6536, akapoor@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance between CEUS and CT (time frame: (Baseline, follow up at 3, 6, 9, & 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.