MRI Hydronephrosis Study

Not Applicable

Withdrawn

• Conditions: Kidney Swelling; Hydronephrosis
• Interventions: Procedure: Ultrasound exam; Procedure: MRI (Magnetic resonance imaging)

• Registration Number: NCT01588340
• Lead Sponsor: University of Michigan

Brief Summary

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01
• Primary Completion: 2017-06
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children 2 years of age and younger
• Diagnosed with hydronephrosis and scheduled for an ultrasound scan

Read More

Exclusion Criteria

• Healthy subjects

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound exam	Ultrasound exam	A noncontrast ultrasound examination
MRI	MRI (Magnetic resonance imaging)	The patient will have a rapid noncontrast MRI (magnetic resonance imaging) that will take approximately 15 minutes to complete.

Primary Outcome Measures

Name	Time	Method
To assess the value of a rapid noncontrast MRI not requiring sedation to ultrasound in accurately diagnosing hydronephrosis in the pediatric patient.	45 minutes	A rapid MRI exam will be performed without IV contrast material or sedation

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States