MRI Hydronephrosis Study
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|ClinicalTrials.gov Identifier: NCT01588340|
Recruitment Status : Withdrawn (PI leaving institution)
First Posted : April 30, 2012
Last Update Posted : June 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hydronephrosis Kidney Swelling||Procedure: MRI (Magnetic resonance imaging) Procedure: Ultrasound exam||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||January 2018|
Active Comparator: MRI
The patient will have a rapid noncontrast MRI (magnetic resonance imaging) that will take approximately 15 minutes to complete.
Procedure: MRI (Magnetic resonance imaging)
Subject will complete a 15 minute scan in the MRI
Active Comparator: Ultrasound exam
A noncontrast ultrasound examination
Procedure: Ultrasound exam
The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588340
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|