Multi-parametric Functional MRI in Patients of Chronic Kidney Disease

October 10, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

Quantitative Mapping Based on Multi-parametric Functional MRI to Evaluate Renal Functions and Microstructure in Chronic Kidney Disease

To explore the value of MR Fingerprinting-generated quantitative maps combined with ASL renal perfusion imaging in the assessment of renal impairment in chronic kidney disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease (CKD) has become an important public health problem threatening human health worldwide. The prevalence rate of CKD in Chinese adults is 10.8%, but the awareness rate and diagnosis rate are generally low. At present, the assessment of renal impairment in CKD mainly relies on laboratory tests, such as estimated glomerular filtration rate (eGFR) and urinary protein/creatinine ratio, and the value of functional MRI in the assessment of renal impairment in patients with CKD is unclear. As a new sequence still in the scientific research stage, MR Fingerprinting can simultaneously generate quantitative T1 maps, T2 maps and proton-weighted images in one breath holding scan, with short scanning time, high repeatability and accuracy. It has been proved that quantitative techniques of T1 mapping and T2 mapping are valuable for evaluating the degree of renal fibrosis and water content. Kidney is a blood-rich organ, and the blood flow of kidney is of great significance to the evaluation of renal function. ASL uses hydrogen protons in arterial blood as an endogenous tracer to evaluate tissue blood perfusion, and can quantitatively evaluate renal blood perfusion in patients with CKD without the use of exogenous contrast agents, avoiding the risk of aggravated renal damage and nephrogenic fibrosis caused by injection of gadoline-containing contrast agents. The objective of our study was to explore the value of MRF sequence-generated quantitative maps combined with ASL renal perfusion imaging in the assessment of renal impairment in chronic kidney disease.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who were diagnosed with chronic kidney disease by renal biopsy

Description

Inclusion Criteria:

  • Patients diagnosed with chronic kidney disease (CKD) by renal biopsy

Exclusion Criteria:

  • Patients with serious underlying diseases
  • Patients with MRI incompatible metal implants and contraindications such as claustrophobia
  • Patients with imperfect clinical data and pathological data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CKD
Chronic Kidney Disease
Diagnostic test: MRI
MR Fingerprinting and ASL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T1 and T2 value
Time Frame: 3 months
T1 and T2 value generated by MR Fingerprinting
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-SR-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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