: 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.
Condition or disease | Intervention/treatment | Phase |
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Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys | Device: MRE exam | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All patients will realize Magnetic Resonance Elastography exam |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM) |
Actual Study Start Date : | July 24, 2019 |
Actual Primary Completion Date : | December 10, 2020 |
Actual Study Completion Date : | December 12, 2020 |
Arm | Intervention/treatment |
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Experimental: MRE exam
Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences
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Device: MRE exam
Magnetic Resonance Elastography
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
CHU Bordeaux | |
Bordeaux, France |
Tracking Information | |||||
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First Submitted Date ICMJE | April 12, 2019 | ||||
First Posted Date ICMJE | April 17, 2019 | ||||
Last Update Posted Date | March 26, 2021 | ||||
Actual Study Start Date ICMJE | July 24, 2019 | ||||
Actual Primary Completion Date | December 10, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mean value of renal elasticity [ Time Frame: Baseline (defined as during MRE exam) ] 5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Average value of renal elasticity [ Time Frame: Baseline (defined as during MRE exam) ] 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
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM) | ||||
Official Title ICMJE | Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM) | ||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: All patients will realize Magnetic Resonance Elastography exam Masking: None (Open Label)Primary Purpose: Diagnostic |
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Condition ICMJE | Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys | ||||
Intervention ICMJE | Device: MRE exam
Magnetic Resonance Elastography
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Study Arms ICMJE | Experimental: MRE exam
Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences
Intervention: Device: MRE exam
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
73 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Actual Study Completion Date ICMJE | December 12, 2020 | ||||
Actual Primary Completion Date | December 10, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03918161 | ||||
Other Study ID Numbers ICMJE | CHUBX 2019/17 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Hospital, Bordeaux | ||||
Study Sponsor ICMJE | University Hospital, Bordeaux | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University Hospital, Bordeaux | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |