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Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

Primary Purpose

Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRE exam
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys focused on measuring Interstitial fibrosis, Tubular atrophy Renal transplantation, Renal allograft, Magnetic Resonance Imaging, Elastography, non-invasive diagnosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18yrs;
  • Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control;
  • Signed informed consent;
  • Affiliated or beneficiary of health insurance

Exclusion Criteria:

  • Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (> 80%) on Doppler;
  • Pregnant or nursing women;
  • Contraindications to MRI;
  • Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRE exam

Arm Description

Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences

Outcomes

Primary Outcome Measures

Mean value of renal elasticity
5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)

Secondary Outcome Measures

Average value of renal elasticity
measured in 10 areas of the graft Intra-renal inflammation, tubulitis, chronic vascular and glomerular lesions measured semi-quantitatively by the pathologist following the Banff classification

Full Information

First Posted
April 12, 2019
Last Updated
March 25, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03918161
Brief Title
Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
Official Title
Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 12, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control. The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.
Detailed Description
The natural history of interstitial fibrosis/tubular atrophy (IF/TA) is a common mechanism of disease progression of transplanted kidneys. The process has been well studied through protocol biopsies. The early phase is characterized by fibrogenesis and the emergence of tubulo-interstitial damage due to immunologic phenomena; the late phase is characterized by the worsening of parenchymal lesions and the occurrence of glomerular sclerosis leading to graft loss. Today, non-invasive markers of these pathological changes are missing and the protocol biopsies are still the only reliable tool for the diagnosis of IF/TA. Elasticity imaging has already been proven in the management of chronic liver diseases with Fibroscan. In the field of renal diseases, several studies have been carried out in ultrasound elastography on renal grafts but the renal elastography is more difficult due to the complexity of the kidney (deep organ, two compartments, high vascularity). All these parameters have an influence on the elasticity measures. The elastography imaging is also performed in MRI (Magnetic resonance imaging): The Magnetic Resonance Elastography (MRE). MRE is less subject to variations in depth, to the experience of the operator and to allow an overall evaluation of the graft. The potentially eligible patients will be recruited by the nephrologist during a consultation in which renal biopsy is scheduled (as part of current practice). Patients meeting the inclusion criteria and having no exclusion criteria will be offered to participate in this study. If accepted, the only examination specific to this research, the MRE, will be scheduled to be performed the same day as the renal biopsy. This MRE is painless, non-irradiating, and does not require the injection of contrast medium. The participation of the patient ends when he leaves the hospital after the biopsy procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys
Keywords
Interstitial fibrosis, Tubular atrophy Renal transplantation, Renal allograft, Magnetic Resonance Imaging, Elastography, non-invasive diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will realize Magnetic Resonance Elastography exam
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRE exam
Arm Type
Experimental
Arm Description
Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences
Intervention Type
Device
Intervention Name(s)
MRE exam
Intervention Description
Magnetic Resonance Elastography
Primary Outcome Measure Information:
Title
Mean value of renal elasticity
Description
5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)
Time Frame
Baseline (defined as during MRE exam)
Secondary Outcome Measure Information:
Title
Average value of renal elasticity
Description
measured in 10 areas of the graft Intra-renal inflammation, tubulitis, chronic vascular and glomerular lesions measured semi-quantitatively by the pathologist following the Banff classification
Time Frame
Baseline (defined as during MRE exam)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18yrs; Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control; Signed informed consent; Affiliated or beneficiary of health insurance Exclusion Criteria: Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (> 80%) on Doppler; Pregnant or nursing women; Contraindications to MRI; Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

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