Renal NCE-MRI in Healthy Volunteers

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02618460

Enrollment

Registered

2015-12-01

Start date

2015-01-31

Completion date

2015-11-30

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Non-contrast enhanced MRI, healthy volunteers, renal diffusion, renal perfusion

Brief summary

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).

Interventions

DEVICENon contrast-enhanced magnetic resonance imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 59 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026