NCT00301470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 22, 2011

Status Verified

October 1, 2006

Enrollment Period

1.8 years

First QC Date

March 10, 2006

Last Update Submit

July 21, 2011

Conditions

Keywords

Ureter, obstructionDiagnostic techniques, urologicalMRI, functional

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • acceptability of the method by patient

  • reliability of the functional indicators provided by the software programme

Interventions

undergoing both renal scintigraphy and MR within a month

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Chu Angers

Angers, 49033, France

Location

Chu Bordeaux

Bordeaux, 33076, France

Location

Chru Lille

Lille, 59037, France

Location

Ap-Hm Marseille

Marseille, 13005, France

Location

Fondation LENVAL

Nice, 06200, France

Location

AP-HP Trousseau

Paris, 75571, France

Location

AP-HP Saint Vincent de Paul

Paris, 75674, France

Location

AP-HP Robert Debré

Paris, 75935, France

Location

AP-HP Bicêtre

Paris, 94275, France

Location

Chu Poitiers

Poitiers, 86021, France

Location

Chu Reims

Reims, 51092, France

Location

Chu Rennes

Rennes, 35033, France

Location

Chu Rouen

Rouen, 76031, France

Location

Chu Strasbourg

Strasbourg, 67091, France

Location

Chu Tours

Tours, 37044, France

Location

CHU NANCY Hôpital Brabois enfant

Vandœuvre-lès-Nancy, 54011, France

Location

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michel CLAUDON, PhD

    Service de Radiologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 13, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

July 22, 2011

Record last verified: 2006-10

Locations