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GFR Measurement With Contrast-enhanced Dynamic MRI (IREN)

Primary Purpose

Transplantation, Kidney, Graft Occlusion, Vascular

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Contrast-enhanced dynamic MRI
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transplantation, Kidney focused on measuring Glomerular filtration rate measurement, Contrast-enhanced dynamic MR imaging, Renal transplant recipients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Age ≥ 18 yo at the time of inclusion
  • Negative pregnancy test
  • Affiliation to the Social Security
  • Written informed consent signed

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Renal transplant recipients

Outcomes

Primary Outcome Measures

GFR according to MRI and Cr51 measurements on the same day

Secondary Outcome Measures

Full Information

First Posted
November 22, 2007
Last Updated
May 21, 2013
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00614081
Brief Title
GFR Measurement With Contrast-enhanced Dynamic MRI
Acronym
IREN
Official Title
Measurement of Glomerular Filtration Rate With Contrast-enhanced Dynamic MR Imaging in Renal Transplant Recipients: Evaluation of the Agreement With the Cr51 -EDTA Method and of Reproducibility
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cr51- EDTA method is considered the reference method for measurement of glomerular filtration rate (GFR). However, this method requires several hours and several blood and urinary samplings. Therefore, the ability to get access to this parameter with a simple, valid and reliable method would be a significant progress in clinical follow-up of patients with renal disease. Contrast-enhanced dynamic MRI is now able to give this access to functional parameters as GFR, rapidly and non invasively, becoming an alternative to Cr51-EDTA method. If the acquisition method has been optimized, some problems remain unsolved: is the movement correction worthwhile for the accuracy of the measurement ? Which model provides the most accurate results ? What is the best way to calculate the total GFR (addition of all the voxels or the product of a mean value by the cortical volume)? These questions can be answered only by a comparison with a reference method. The reference method will be performed after standard hydration, with intravenous injection of 100 µCi of Cr51- EDTA and urinary and blood samplings every 30 minutes during 3h. Dynamic MRI will be performed with fast 3D T1-weighted gradient-echo sequences during 5 minutes after injection of a third of a clinical dose of gadolinium. Post-treatment of images will be done on an off-line program allowing movement correction, conversion of signal intensity into concentration and application of different models. 8 combinations of post-treatment will be tested and compared to the reference method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation, Kidney, Graft Occlusion, Vascular
Keywords
Glomerular filtration rate measurement, Contrast-enhanced dynamic MR imaging, Renal transplant recipients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Renal transplant recipients
Intervention Type
Device
Intervention Name(s)
Contrast-enhanced dynamic MRI
Primary Outcome Measure Information:
Title
GFR according to MRI and Cr51 measurements on the same day
Time Frame
The same day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Age ≥ 18 yo at the time of inclusion Negative pregnancy test Affiliation to the Social Security Written informed consent signed Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEREZ Paul, Dr
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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GFR Measurement With Contrast-enhanced Dynamic MRI

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