MRI Technical Development and Applications in Kidney Disease

NCT02421497 | Not Yet Recruiting

• 1 other identifier: 1410M54981
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.develop, customize, and optimize anatomic and functional MRI methods,
2. 2.explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and
3. 3.investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.

Conditions

Chronic Kidney Diseases; Kidney Transplantation; Dialysis; Cognition Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  up to three years

• 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.

  Up to three years

Study Arms (5)

Normal Healthy Volunteer

Non-CKD Control

Chronic Kidney Disease (CKD)

Dialysis Patients

Renal Transplant Recipients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \. Healthy Volunteer

You may not qualify if:

• Ferromagnetic implants
• Any foreign metal objects in the body
• History of shrapnel or shot gun injury
• Cardiac pacemakers
• Defibrillator
• Neuronal stimulator
• Magnetic aneurysm clip
• Large tattoos on the abdomen or the brain and neck
• Hip replacement
• Too large to fit in the magnet (body mass index \>= 40, approx.)
• Severe claustrophobia
• Women with pregnancy
• For Specific Aim 2: Pilot Studies with Patients
• Studies for CKD
• English- speaking as primary language.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cognition Disorders

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xiufeng Li, Ph.D.

  Univesity of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiufeng Li, Ph.D.

CONTACT

612-625-7872; lixx1607@umn.edu

Michelle Hartwig

CONTACT

612-626-0021; mhartwig@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start (Estimated): June 30, 2028
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)