MRI Technical Development and Applications in Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Minnesota
About this trial
Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to:
1. develop, customize, and optimize anatomic and functional MRI methods, 2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and 3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.
In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Ferromagnetic implants
Any foreign metal objects in the body
History of shrapnel or shot gun injury
Cardiac pacemakers
Trial population
The study populations vary across specific aims: normal healthy or control volunteers for Specific Aim 1, CKD patients and renal transplant recipients for Specific Aim 2.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
180 Participants
are grouped into 5 trial groupsGroup A: Normal Healthy Volunteer
Group B: Non-CKD Control
Group C: Chronic Kidney Disease (CKD)
Group D: Dialysis Patients
Group E: Renal Transplant Recipients
Trial outcomes
Primary outcomes
1
Correspondence of MRI measures with clinical metrics (i.e. eGFR) and routinely assessed cognitive functions from CKD and ESRD patients.
MRI measures will be evaluated both globally and regionally (e.g. frontal lobe and the hippocampus of the brain, renal cortex and medulla in each and both kidneys). The correlations among MRI measurements, the degree of CKD disease (as evaluated by eGFR) and the severity of cognitive impairment will be assessed using both cross-sectional and longitudinal analyses. Non-parametric analysis approach will be used instead of parametric if appropriate.
Time frame
up to three years2
The potential of MRI methods in the evaluation of post-transplant kidneys.
For each region in kidneys (renal cortex and medulla), each MRI measurement from the cross-sectional studies of transplant recipients with stable renal functional will be correlated to the levels of transplant kidney function (e.g. eGFR). Imaging results from transplant recipients with unstable renal function will be compared between patients with and without diagnosed acute rejection, and before and after the acute rejection treatment for patients with positive response. Note: For both outcomes, multi-parametric MRI measurements will be used in the evaluation, including but not limited to MRI relaxation times, blood flow and diffusion.
Time frame
Up to three yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: