Functional MR Urography
Primary Purpose
Ureteral Obstruction
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MR urography
Sponsored by
About this trial
This is an interventional diagnostic trial for Ureteral Obstruction focused on measuring Ureter, obstruction, Diagnostic techniques, urological, MRI, functional
Eligibility 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
Sites / Locations
- Chu Angers
- Chu Bordeaux
- Chru Lille
- Ap-Hm Marseille
- Fondation LENVAL
- AP-HP Trousseau
- AP-HP Saint Vincent de Paul
- AP-HP Robert Debré
- AP-HP Bicêtre
- Chu Poitiers
- Chu Reims
- Chu Rennes
- Chu Rouen
- Chu Strasbourg
- Chu Tours
- CHU NANCY Hôpital Brabois enfant
Outcomes
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
Full Information
NCT ID
NCT00301470
First Posted
March 10, 2006
Last Updated
July 21, 2011
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT00301470
Brief Title
Functional MR Urography
Official Title
Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Obstruction
Keywords
Ureter, obstruction, Diagnostic techniques, urological, MRI, functional
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
MR urography
Intervention Description
undergoing both renal scintigraphy and MR within a month
Primary Outcome Measure Information:
Title
Main medical criterion
Title
percentage of relative renal function of the obstructed kidney
Title
Main economical criterion
Title
reduction of patient's management cost in the case of a suspicion of chronic or intermittent urinary obstruction
Secondary Outcome Measure Information:
Title
acceptability of the method by patient
Title
reliability of the functional indicators provided by the software programme
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel CLAUDON, PhD
Organizational Affiliation
Service de Radiologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Chu Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Ap-Hm Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Fondation LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
AP-HP Trousseau
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
AP-HP Saint Vincent de Paul
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
AP-HP Robert Debré
City
Paris
ZIP/Postal Code
75935
Country
France
Facility Name
AP-HP Bicêtre
City
Paris
ZIP/Postal Code
94275
Country
France
Facility Name
Chu Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Chu Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Chu Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU NANCY Hôpital Brabois enfant
City
Vandoeuvre les Nancy
ZIP/Postal Code
54011
Country
France
12. IPD Sharing Statement
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Functional MR Urography
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