NCT05498532

Brief Summary

Pyelo-ureteral junction syndrome is the most common urological abnormality in children. Functional MRI has been evaluated several times and has shown good correlation with scintigraphy, but tends to overestimate results. Moreover, those studies included a small number of cases. Its sensitivity to detect crossing polar vessels is limited. The investigators aimed to evaluate, in patients between 0 and 1 year old, the correlation between MRI and scintigraphy differential renal function. The secondary objectives are the evaluation of MRI performances to detect polar vessels; the comparison of surgery times depending on MRI-only realization or MRI and scintigraphy realization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 16, 2026

Status Verified

August 1, 2022

Enrollment Period

14 days

First QC Date

August 10, 2022

Last Update Submit

June 15, 2026

Conditions

Keywords

PUJSMRIScintigraphyPolar Vessel

Outcome Measures

Primary Outcomes (1)

  • MRI and scintigraphy differential renal function correlation

    Evaluation of differential renal function between MRI and scintigraphy in children between 0 and 1 year old ; Pearson correlation coefficient

    from january 2007 to december 2021

Secondary Outcomes (3)

  • MRI and scintigraphy differential renal function correlation in operated patient

    from january 2007 to december 2021

  • Time difference in patient operated for PUJS depending on MRI realisation ou MRI and scintigraphy realisation

    from january 2007 to december 2021

  • performance of MRI in detecting polar vessel

    from january 2007 to december 2021

Study Arms (1)

PUJS patients

Patients between 0 and 17 years old treated or followed for pyelo-ureteral junction syndrome.

Diagnostic Test: Functional MRI

Interventions

Functional MRIDIAGNOSTIC_TEST

Anatomical MRI : T2 fiesta, SSFE, HASTE ; 3D T2 ; T1 FAT SAT ; LAVA Functional MRI : T1 FAT SAT with gadolinium

Also known as: Renal Scintigraphy
PUJS patients

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children between 0 and 17 years old followed for pyelo-ureteral junction syndrome in the Children hospital of Nancy.

You may qualify if:

  • children between 0 and 17 years old
  • followed for pyelo-ureteral junction syndrome

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54 511, France

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Charles Mazeaud

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Praticien hospitalier universitaire

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

September 1, 2022

Primary Completion

September 15, 2022

Study Completion

December 30, 2022

Last Updated

June 16, 2026

Record last verified: 2022-08

Locations