Functional MR Urography

July 21, 2011 updated by: Central Hospital, Nancy, France

Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults

The objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is demonstrated, it would be possible to have both the morphological and functional approach of an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The initial management and the follow-up of a patient presenting with chronic or intermittent obstruction is depending on clinical, biological factors and of imaging data, including the presence and degree of dilatation of pelvo-caliceal cavities and of functional consequences of such an obstruction.

The primary objectives of the study are:

  • to evaluate the feasibility and reliability of the measurement of the relative renal function by MR urography compared to renal scintigraphy in the management of patients presenting with chronic and intermittent urinary obstruction in adults and children.
  • if the accuracy of the two methods is demonstrated as equivalent, to conduct a medico-economic evaluation of functional MR Urography compared to renal scintigraphy, and show potential lower costs.

The secondary objectives are:

  • to compare the diagnostic accuracy of various parameters of analysis of functional MR urography data, previously published in the literature, and determine indicators for predicting urinary obstruction
  • to evaluate the interest of these indicators after surgical treatment of obstruction, or during the follow-up of patients
  • to draw up a program of analysis and treatment of MR urography data, available for all centres whatever their MR unit.

The current study has a multicentric, observational, prospective design for the evaluation of a diagnostic strategy. It includes 16 French hospitals.

The main clinical hypothesis is that during one single MR examination, by the association of a morphological diagnostic phase and a functional phase, it will be possible to extract functional parameters having the same accuracy that renal scintigraphy in the determination of relative renal function.

The targeted recruitment is of 550 patients for two years. The MR and scintigraphy collected data will be reviewed in one site by experts at the end of the study. The university hospital of Nancy is in charge of coordinating the study.

Points of expected impact of the study are:

  1. a shortening of the duration of patients management by replacing two examinations (MR and scintigraphy) by one single examination (MR )
  2. a reduction of delivered exposure to diagnostic radiation, by eliminating renal scintigraphy in the initial diagnostic and follow-up of children an adults.
  3. potential applications in improving the spatial resolution of MR urography after correction of artefacts such as respiratory motion.
  4. the publication of clinical recommendations by the National Scientific Societies supporting the trial.

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHU Angers
      • Bordeaux, France, 33076
        • CHU Bordeaux
      • Lille, France, 59037
        • CHRU Lille
      • Marseille, France, 13005
        • AP-HM Marseille
      • Nice, France, 06200
        • Fondation Lenval
      • Paris, France, 75571
        • AP-HP Trousseau
      • Paris, France, 75674
        • AP-HP Saint Vincent de Paul
      • Paris, France, 75935
        • AP-HP Robert Debré
      • Paris, France, 94275
        • AP-HP Bicetre
      • Poitiers, France, 86021
        • CHU Poitiers
      • Reims, France, 51092
        • CHU Reims
      • Rennes, France, 35033
        • CHU Rennes
      • Rouen, France, 76031
        • CHU Rouen
      • Strasbourg, France, 67091
        • CHU Strasbourg
      • Tours, France, 37044
        • CHU Tours
      • Vandoeuvre les Nancy, France, 54011
        • CHU NANCY Hôpital Brabois enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

children (age > 1 month) and adults chronic or intermittent urinary obstruction suspected by the demonstration of uni- or bilateral dilatation of pelvo-caliceal cavities by ultrasound or CT scan.

undergoing both renal scintigraphy and MR within a month

Exclusion Criteria:

acute urinary obstruction unilateral renal agenesia and ectopic kidney renal transplantation contra-indications to MR : pace-maker, claustrophobia contra-indications to the administration of Gadolinium chelates, including pregnancy, allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Main medical criterion
percentage of relative renal function of the obstructed kidney
Main economical criterion
reduction of patient's management cost in the case of a suspicion of chronic or intermittent urinary obstruction

Secondary Outcome Measures

Outcome Measure
acceptability of the method by patient
reliability of the functional indicators provided by the software programme

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Michel CLAUDON, PhD, Service de Radiologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 2005 - 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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