Renal NCE-MRI in Healthy Volunteers
Non-contrast Enhanced MR Imaging of the Kidney in Healthy Volunteers
1 other identifier
interventional
16
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 20, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedJanuary 28, 2016
January 1, 2016
10 months
November 20, 2015
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Study Arms (1)
Whole Group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age ≥ 20 and ≤59 years ;
- Healthy volunteers;
- Written informed consent.
You may not qualify if:
- Pregnancy (due to safety reasons).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mario Negri Institute for Pharmacological Researchlead
- EC-DG Researchcollaborator
Study Sites (1)
Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII
Bergamo, Bergamo, 24127, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
December 1, 2015
Study Start
January 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 28, 2016
Record last verified: 2016-01