GFR Measurement With Contrast-enhanced Dynamic MRI (IREN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00614081
First received: November 22, 2007
Last updated: May 21, 2013
Last verified: May 2013
  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

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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 ]

Enrollment: 71
Study Start Date: January 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614081

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

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00614081     History of Changes
Other Study ID Numbers: 7825, 2005-029
Study First Received: November 22, 2007
Last Updated: May 21, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 29, 2014