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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR urography | Device | undergoing both renal scintigraphy and MR within a month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| acceptability of the method by patient | ||
| reliability of the functional indicators provided by the software programme |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Michel CLAUDON, PhD | Service de Radiologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | 49033 | France | |||
| Chu Bordeaux |
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| ID | Term |
|---|---|
| D014517 | Ureteral Obstruction |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Bordeaux |
| 33076 |
| France |
| Chru Lille | Lille | 59037 | France |
| Ap-Hm Marseille | Marseille | 13005 | France |
| Fondation LENVAL | Nice | 06200 | France |
| AP-HP Trousseau | Paris | 75571 | France |
| AP-HP Saint Vincent de Paul | Paris | 75674 | France |
| AP-HP Robert Debré | Paris | 75935 | France |
| AP-HP Bicêtre | Paris | 94275 | France |
| Chu Poitiers | Poitiers | 86021 | France |
| Chu Reims | Reims | 51092 | France |
| Chu Rennes | Rennes | 35033 | France |
| Chu Rouen | Rouen | 76031 | France |
| Chu Strasbourg | Strasbourg | 67091 | France |
| Chu Tours | Tours | 37044 | France |
| CHU NANCY Hôpital Brabois enfant | Vandœuvre-lès-Nancy | 54011 | France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |