Functional MR Urography
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults|
- 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
- acceptability of the method by patient
- reliability of the functional indicators provided by the software programme
|Study Start Date:||March 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Device: MR urography
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:
- a shortening of the duration of patients management by replacing two examinations (MR and scintigraphy) by one single examination (MR )
- a reduction of delivered exposure to diagnostic radiation, by eliminating renal scintigraphy in the initial diagnostic and follow-up of children an adults.
- potential applications in improving the spatial resolution of MR urography after correction of artefacts such as respiratory motion.
- the publication of clinical recommendations by the National Scientific Societies supporting the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301470
|Angers, France, 49033|
|Bordeaux, France, 33076|
|Lille, France, 59037|
|Marseille, France, 13005|
|Nice, France, 06200|
|Paris, France, 75571|
|AP-HP Saint Vincent de Paul|
|Paris, France, 75674|
|AP-HP Robert Debré|
|Paris, France, 75935|
|Paris, France, 94275|
|Poitiers, France, 86021|
|Reims, France, 51092|
|Rennes, France, 35033|
|Rouen, France, 76031|
|Strasbourg, France, 67091|
|Tours, France, 37044|
|CHU NANCY Hôpital Brabois enfant|
|Vandoeuvre les Nancy, France, 54011|
|Principal Investigator:||Michel CLAUDON, PhD||Service de Radiologie|