Renal NCE-MRI in Healthy Volunteers

Study Overview
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Brief Summary
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Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy. Additional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA), phase-contrast MRI), which could be used in combination with structural MRI in a single acquisition session, have been identified to investigate in more detail renal function and structure, opening the possibility to estimate local renal diffusion and blood perfusion, beyond providing high-resolution anatomical accuracy. Preliminary to the identification of novel imaging biomarkers of renal disease progression, perfusion and diffusion MR sequences need to be optimized for the renal compartment. Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and diffusion changes in pathological kidneys as compared to normal and physiological condition. The objective of this study is to provide normal control NCE-MRI sequences to be used as reference for the investigation of perfusion and diffusion changes in the kidney of patients affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal dominant polycystic kidney disease).

Official Title
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Non-contrast Enhanced MR Imaging of the Kidney in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Device: Non contrast-enhanced magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 and ≤59 years ; Healthy volunteers; Written informed consent. Exclusion Criteria: Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment; Pregnancy (due to safety reasons).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Group<br> | Device: Non contrast-enhanced magnetic resonance imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent Diffusion Coefficient (ADC) | Renal perfusion and diffusion parameter assessed by Diffusion Weighted Imaging (DWI) MRI, characterising normal physiology. | At baseline. | 
| T2* | Renal blood oxygenation parameter assessed by Blood Oxygenation Level Dependent (BOLD) MRI, characterising normal physiology. | At baseline. | 
| Renal artery flow. | Renal perfusion parameter assessed by Phase-Contrast (PC) MRI, characterising normal physiology. | At baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-contrast enhanced MRI, healthy volunteers, renal diffusion, renal perfusion