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| Sponsor: | Central Hospital, Nancy, France |
|---|---|
| Information provided by: | Central Hospital, Nancy, France |
| ClinicalTrials.gov Identifier: | NCT00301470 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ureteral Obstruction |
Device: MR urography |
Phase IV |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 550 |
| Study Start Date: | March 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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:
The secondary objectives are:
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:
Eligibility| Ages Eligible for Study: | 1 Month and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Chu Angers | |
| Angers, France, 49033 | |
| Chu Bordeaux | |
| Bordeaux, France, 33076 | |
| Chru Lille | |
| Lille, France, 59037 | |
| Ap-Hm Marseille | |
| Marseille, France, 13005 | |
| Fondation LENVAL | |
| Nice, France, 06200 | |
| AP-HP Bicêtre | |
| Paris, France, 94275 | |
| AP-HP Robert Debré | |
| Paris, France, 75935 | |
| AP-HP Saint Vincent de Paul | |
| Paris, France, 75674 | |
| AP-HP Trousseau | |
| Paris, France, 75571 | |
| Chu Poitiers | |
| Poitiers, France, 86021 | |
| Chu Reims | |
| Reims, France, 51092 | |
| Chu Rennes | |
| Rennes, France, 35033 | |
| Chu Rouen | |
| Rouen, France, 76031 | |
| Chu Strasbourg | |
| Strasbourg, France, 67091 | |
| Chu Tours | |
| Tours, France, 37044 | |
| CHU NANCY Hôpital Brabois enfant | |
| Vandoeuvre les Nancy, France, 54011 | |
| Principal Investigator: | Michel CLAUDON, PhD | Service de Radiologie |
More Information
| Responsible Party: | Philippe Boulangé, Directeur de la Recherche et de l'Innovation, Direction de la Recherche et de l'Innovation |
| ClinicalTrials.gov Identifier: | NCT00301470 History of Changes |
| Other Study ID Numbers: | PI 2005 - 01 |
| Study First Received: | March 10, 2006 |
| Last Updated: | July 21, 2011 |
| Health Authority: | France: Ministry of Health |
|
Ureter, obstruction Diagnostic techniques, urological MRI, functional |
|
Ureteral Obstruction Ureteral Diseases Urologic Diseases |