GFR Measurement With Contrast-enhanced Dynamic MRI (IREN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00614081
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : May 22, 2013
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Transplantation, Kidney Graft Occlusion, Vascular Device: Contrast-enhanced dynamic MRI Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : January 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Renal transplant recipients
Device: Contrast-enhanced dynamic MRI

Primary Outcome Measures :
  1. GFR according to MRI and Cr51 measurements on the same day [ Time Frame: The same day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00614081

Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Study Chair: PEREZ Paul, Dr University Hospital, Bordeaux, France

Responsible Party: University Hospital, Bordeaux Identifier: NCT00614081     History of Changes
Other Study ID Numbers: 7825
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by University Hospital, Bordeaux:
Glomerular filtration rate measurement
Contrast-enhanced dynamic MR imaging
Renal transplant recipients

Additional relevant MeSH terms:
Graft Occlusion, Vascular
Postoperative Complications
Pathologic Processes