MRI Hydronephrosis Study
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Purpose
The purpose of this study is to compare a rapid noncontrast MRI protocol not requiring sedation to ultrasound in the assessment of hydronephrosis.
| Condition | Intervention |
|---|---|
|
Hydronephrosis Kidney Swelling |
Procedure: MRI (Magnetic resonance imaging) Procedure: Ultrasound exam |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis |
- 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 ] [ Designated as safety issue: Yes ]A rapid MRI exam will be performed without IV contrast material or sedation
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children 2 years of age and younger
- Diagnosed with hydronephrosis and scheduled for an ultrasound scan
Exclusion Criteria:
- Healthy subjects
Contacts and Locations| Contact: Jonathan Dillman, M.D. | 734-763-2571 | |
| Contact: James Pool, CRC | 734-615-7800 |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Jonathan Dillman, M.D. | |
More Information
No publications provided
| Responsible Party: | Jonathan R. Dillman M.D., Principal Investigator, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01588340 History of Changes |
| Other Study ID Numbers: | HUM00055762 |
| Study First Received: | April 26, 2012 |
| Last Updated: | June 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Edema Hydronephrosis Signs and Symptoms Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013