HydronephrosisNCT01588340
MRI Hydronephrosis Study
A study testing MRI (Magnetic resonance imaging) and Ultrasound exam in people with Hydronephrosis and Kidney Swelling, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Hydronephrosis, Kidney Swelling
- What is being tested?
- MRI (Magnetic resonance imaging) and Ultrasound exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2018
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2 years of age and younger
- Diagnosed with hydronephrosis and scheduled for an ultrasound scan
Who cannot join
- Healthy subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis
The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis.
Read the detailed description
Ultrasound is the most commonly performed imaging modality used to assess hydronephrosis. The average renal ultrasound exam takes about 15-25 minutes to complete, however, it does have several disadvantages, including substantial operator dependence, having to rely on an adequate "sonographic window" to see the structures of interest and difficulty in visualization of portions of the kidney and urinary tracts.
Recent MRI advances have made rapid imaging possible. Such imaging has minimized motion related artifacts and need for sedation.
This study is to compare traditional ultrasound imaging to a raid noncontrast protocol MRI examination of the kidneys and urinary tract that would require no sedation and less than 15 minutes to perform.
- Conditions
- Hydronephrosis, Kidney Swelling
- Being tested
- MRI (Magnetic resonance imaging), Ultrasound exam
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI (Magnetic resonance imaging)Procedure or surgery
Subject will complete a 15 minute scan in the MRI
Ultrasound examProcedure or surgery
The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete
| Study group | Role | What they receive |
|---|---|---|
| MRI | Active comparator | The patient will have a rapid noncontrast MRI (magnetic resonance imaging) that will take approximately 15 minutes to complete. Receives: Procedure: MRI (Magnetic resonance imaging) |
| Ultrasound exam | Active comparator | A noncontrast ultrasound examination Receives: Procedure: Ultrasound exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the value of a rapid noncontrast MRI not requiring sedation to ultrasound in accurately diagnosing hydronephrosis in the pediatric patient.
A rapid MRI exam will be performed without IV contrast material or sedation
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydronephrosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Dillman M.D., University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588340
- Sponsor's protocol ID
- HUM00055762
- Status last verified
- May 2015
- First submitted
- 26 Apr 2012
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis
- ClinicalTrials.gov ID
- NCT01588340
- Acronym / sponsor ID
- HUM00055762
- Conditions
- Hydronephrosis, Kidney Swelling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 30 Apr 2012 (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.
The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis.
Detailed description
Ultrasound is the most commonly performed imaging modality used to assess hydronephrosis. The average renal ultrasound exam takes about 15-25 minutes to complete, however, it does have several disadvantages, including substantial operator dependence, having to rely on an adequate "sonographic window" to see the structures of interest and difficulty in visualization of portions of the kidney and urinary tracts.
Recent MRI advances have made rapid imaging possible. Such imaging has minimized motion related artifacts and need for sedation.
This study is to compare traditional ultrasound imaging to a raid noncontrast protocol MRI examination of the kidneys and urinary tract that would require no sedation and less than 15 minutes to perform.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI | Active comparator | Procedure: MRI (Magnetic resonance imaging)The patient will have a rapid noncontrast MRI (magnetic resonance imaging) that will take approximately 15 minutes to complete. |
| Ultrasound exam | Active comparator | Procedure: Ultrasound examA noncontrast ultrasound examination |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 2 years of age and younger
- Diagnosed with hydronephrosis and scheduled for an ultrasound scan
Key exclusion criteria (1 listed)
- Healthy subjects
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 |
|---|---|---|
| MRI (Magnetic resonance imaging)Subject will complete a 15 minute scan in the MRI | Procedure or surgery | MRI |
| Ultrasound examThe subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete | Procedure or surgery | Ultrasound exam |
Primary outcome
To assess the value of a rapid noncontrast MRI not requiring sedation to ultrasound in accurately diagnosing hydronephrosis in the pediatric patient.
Time frame: 45 minutes
A rapid MRI exam will be performed without IV contrast material or sedation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI (Magnetic resonance imaging) and Ultrasound exam in people with Hydronephrosis and Kidney Swelling, run by University of Michigan at 1 site in United States.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Jun 2015. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the value of a rapid noncontrast MRI not requiring sedation to ultrasound in accurately diagnosing hydronephrosis in the pediatric patient. (time frame: 45 minutes). 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 1 Jun 2015.