Renal NCE-MRI in Healthy Volunteers

NCT ID: NCT02618460

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-11-30

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).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Whole Group

Group Type: EXPERIMENTAL

Non contrast-enhanced magnetic resonance imaging

Intervention Type: DEVICE

Interventions

Non contrast-enhanced magnetic resonance imaging

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EC-DG Research

OTHER

Sponsor Role: collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII

Bergamo, Bergamo, Italy

Countries

Italy

Other Identifiers

Renal NCE-MRI in volunteers

Identifier Type: -

Identifier Source: org_study_id