Ureteral Obstruction Clinical Trial
Official title:
Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults
Verified date | October 2006 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 550 |
Est. completion date | March 2008 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Chu Angers | Angers | |
France | Chu Bordeaux | Bordeaux | |
France | Chru Lille | Lille | |
France | Ap-Hm Marseille | Marseille | |
France | Fondation LENVAL | Nice | |
France | AP-HP Bicêtre | Paris | |
France | AP-HP Robert Debré | Paris | |
France | AP-HP Saint Vincent de Paul | Paris | |
France | AP-HP Trousseau | Paris | |
France | Chu Poitiers | Poitiers | |
France | Chu Reims | Reims | |
France | Chu Rennes | Rennes | |
France | Chu Rouen | Rouen | |
France | Chu Strasbourg | Strasbourg | |
France | Chu Tours | Tours | |
France | CHU NANCY Hôpital Brabois enfant | Vandoeuvre les Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Main medical criterion | |||
Primary | percentage of relative renal function of the obstructed kidney | |||
Primary | Main economical criterion | |||
Primary | reduction of patient's management cost in the case of a suspicion of chronic or intermittent urinary obstruction | |||
Secondary | acceptability of the method by patient | |||
Secondary | reliability of the functional indicators provided by the software programme |
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