NCT00614081

Brief Summary

The aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

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

November 22, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

5.2 years

First QC Date

November 22, 2007

Last Update Submit

May 21, 2013

Conditions

Transplantation, KidneyGraft Occlusion, Vascular

Keywords

Glomerular filtration rate measurementContrast-enhanced dynamic MR imagingRenal transplant recipients

Outcome Measures

Primary Outcomes (1)

  • GFR according to MRI and Cr51 measurements on the same day

    The same day

Study Arms (1)

1

EXPERIMENTAL

Renal transplant recipients

Device: Contrast-enhanced dynamic MRI

Interventions

Contrast-enhanced dynamic MRIDEVICE
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a renal transplant presenting with a graft dysfunction or a suspicion of vascular complication (renal artery stenosis…) or of urinary complication (dilatation of excretory system, collection) justifying to perform a non urgent MR examination
  • Calculated glomerular clearance (MDRD method) \> 20 ml/min
  • Negative pregnancy test
  • Affiliation to the Social Security
  • Written informed consent signed

You may not qualify if:

  • Contra-indication to MRI: neurovascular clips, pacemaker, cochlear implant, orbital metallic object, claustrophobic patients…
  • Contra-indication to gadolinium: previous hypersensitivity to Gd-Chelates
  • Pregnancy or breastfeeding women
  • Adult under legal supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Graft Occlusion, Vascular

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • PEREZ Paul, Dr

    University Hospital, Bordeaux, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2007

First Posted

February 13, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

FR(1)