MRI Hydronephrosis Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01588340
First received: April 26, 2012
Last updated: July 21, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588340

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  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: July 21, 2014
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 July 22, 2014