NCT01588340

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

5.3 years

First QC Date

April 26, 2012

Last Update Submit

May 29, 2015

Conditions

HydronephrosisKidney Swelling

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MRI

ACTIVE COMPARATOR

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

Procedure: MRI (Magnetic resonance imaging)

Ultrasound exam

ACTIVE COMPARATOR

A noncontrast ultrasound examination

Procedure: Ultrasound exam

Interventions

MRI (Magnetic resonance imaging)PROCEDURE

Subject will complete a 15 minute scan in the MRI

MRI
Ultrasound examPROCEDURE

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

Ultrasound exam

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Healthy subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hydronephrosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

US(1)