Functional MR Urography

This study has been completed.
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00301470
First received: March 10, 2006
Last updated: July 21, 2011
Last verified: October 2006
  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 4

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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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:
  • acceptability of the method by patient
  • reliability of the functional indicators provided by the software programme

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)
Intervention Details:
    Device: MR urography
    undergoing both renal scintigraphy and MR within a month
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.
  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301470

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 Trousseau
Paris, France, 75571
AP-HP Saint Vincent de Paul
Paris, France, 75674
AP-HP Robert Debré
Paris, France, 75935
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
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Michel CLAUDON, PhD Service de Radiologie
  More Information

No publications provided

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

Keywords provided by Central Hospital, Nancy, France:
Ureter, obstruction
Diagnostic techniques, urological
MRI, functional

Additional relevant MeSH terms:
Ureteral Obstruction
Ureteral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014