Renal NCE-MRI in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618460
• Other study ID #: Renal NCE-MRI in volunteers
• Status: Completed
• Phase: N/A
• First received: November 20, 2015
• Last updated: January 27, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 59 Years

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Non contrast-enhanced magnetic resonance imaging

Locations

Country	Name	City	State
Italy	Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII	Bergamo

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	EC-DG Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparent Diffusion Coefficient (ADC)	Renal perfusion and diffusion parameter assessed by Diffusion Weighted Imaging (DWI) MRI, characterising normal physiology.	At baseline.	No
Primary	T2*	Renal blood oxygenation parameter assessed by Blood Oxygenation Level Dependent (BOLD) MRI, characterising normal physiology.	At baseline.	No
Primary	Renal artery flow.	Renal perfusion parameter assessed by Phase-Contrast (PC) MRI, characterising normal physiology.	At baseline.	No