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Renal NCE-MRI in Healthy Volunteers

M

Mario Negri Institute for Pharmacological Research

Status

Completed

Conditions

Healthy

Treatments

Device: Non contrast-enhanced magnetic resonance imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02618460
Renal NCE-MRI in volunteers

Details and patient eligibility

About

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).

Enrollment

16 patients

Sex

All

Ages

20 to 59 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Whole Group
Experimental group
Treatment:
Device: Non contrast-enhanced magnetic resonance imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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