MRI Hydronephrosis Study

Hydronephrosis Clinical Trial

Official title:

Comparison of Rapid Protocol Noncontrast MRI vs. Ultrasound in the Evaluation of Pediatric Hydronephrosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01588340
• Other study ID #: HUM00055762
• Status: Withdrawn
• Phase: N/A
• First received: April 26, 2012
• Last updated: May 29, 2015
• Start date: February 2012
• Est. completion date: January 2018

Study information

• Verified date: May 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Children 2 years of age and younger

• Diagnosed with hydronephrosis and scheduled for an ultrasound scan

Exclusion Criteria:

• Healthy subjects

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hydronephrosis
• Kidney Swelling

Intervention

Procedure:
• MRI (Magnetic resonance imaging)
Subject will complete a 15 minute scan in the MRI
• Ultrasound exam
The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	45 minutes	Yes