MRI Hydronephrosis Study

NCT ID: NCT01588340

Last Updated: 2015-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-01-31

Brief Summary

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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

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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

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Hydronephrosis Kidney Swelling

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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MRI

The patient will have a rapid noncontrast MRI (magnetic resonance imaging) that will take approximately 15 minutes to complete.

Group Type ACTIVE_COMPARATOR

MRI (Magnetic resonance imaging)

Intervention Type PROCEDURE

Subject will complete a 15 minute scan in the MRI

Ultrasound exam

A noncontrast ultrasound examination

Group Type ACTIVE_COMPARATOR

Ultrasound exam

Intervention Type PROCEDURE

The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete

Interventions

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MRI (Magnetic resonance imaging)

Subject will complete a 15 minute scan in the MRI

Intervention Type PROCEDURE

Ultrasound exam

The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Healthy subjects
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jonathan R. Dillman M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00055762

Identifier Type: -

Identifier Source: org_study_id

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