Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
GFR Measurement With Contrast-Enhanced Dynamic MRI (IREN)
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, January 2008
Sponsored by: University Hospital, Bordeaux
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00614081
  Purpose

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 Intervention
Transplantation, Kidney
Graft Occlusion, Vascular
Device: Contrast-enhanced dynamic MRI

MedlinePlus related topics: Kidney Transplantation
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Single Blind (Outcomes Assessor), Parallel Assignment
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

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • GFR according to MRI and Cr51 measurements on the same day [ Time Frame: The same day ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: January 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Renal transplant recipients
Device: Contrast-enhanced dynamic MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614081

Contacts
Contact: GRENIER Nicolas, Pr 33 (0)5 56 79 55 99 nicolas.grenier@chu-bordeaux.fr

Locations
France
Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Nicolas Grenier, PU-PH     05 56 79 55 99     nicolas.grenier@chu-bordeaux.fr    
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: PEREZ Paul, Dr University Hospital, Bordeaux, France
  More Information

Responsible Party: University Hospital, Bordeaux ( Jean-Pierre LEROY )
Study ID Numbers: 7825, 2005-029
Study First Received: November 22, 2007
Last Updated: January 30, 2008
ClinicalTrials.gov Identifier: NCT00614081  
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Graft Occlusion, Vascular
Postoperative Complications

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009