Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Study Overview
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Brief Summary
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The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

Detailed Description
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The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.

Official Title
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Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Other: MRI 1.5T and 3.0T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Recipient of living donor kidney transplantation 4 or 7 years earlier Competent and able to provide written informed consent; Ability to comply with protocol Exclusion Criteria: Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient. Severe chronic liver, heart or lung disease Undergoing acute rejection Contra-indication to biopsy; bleeding disorders Chronic infection Any active malignancy and undergoing therapy Kidney or ureteric stone Unable to give valid informed consent Known pregnancy or intent to conceive during the study period Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI Federal medical center inmates. Latex allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, unblinded, Parallel, imaging study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 years after kidney transplantation<br>Patients 4 years after KT (N=10); 5 with estimated (e) glomerular filtration rate (GFR) ≤35 mL/min/1.73m2, and 5 with estimated (e) glomerular filtration rate (GFR)>35 mL/min/1.73m2. | Other: MRI 1.5T and 3.0T<br>* Magnetic Resonance Imaging for Renal Fibrosis<br>|
| Experimental: 7 years after kidney transplantation<br>Patients 7 years after KT (N=10); 5 patients with eGFR ≤35 mL/min/1.73m2, and 5 with eGFR>35 mL/min/1.73m2. | Other: MRI 1.5T and 3.0T<br>* Magnetic Resonance Imaging for Renal Fibrosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The values and correlation of f with IF | Correlation of qMT with tissue fibrosis (trichrome) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation of f with renal function attributes and pro-fibrogenic activity | Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors. | 2 years |