Chronic Kidney Disease(CKD)NCT06639685
Multi-parametric Functional MRI in Patients of Chronic Kidney Disease
An observational study of Chronic Kidney Disease(CKD) and MRI, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease(CKD), MRI
- What is being tested?
- MRI
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with chronic kidney disease by renal biopsy
Who may be able to join
- Patients diagnosed with chronic kidney disease (CKD) by renal biopsy
Who cannot join
- Patients with serious underlying diseases
- Patients with MRI incompatible metal implants and contraindications such as claustrophobia
- Patients with imperfect clinical data and pathological data
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Yue Wang, 025-68306222, jsphkjwy@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease(CKD), MRI
- Being tested
- MRI
- Keywords
- Chronic Kidney Disease, MR Fingerprinting, ASL
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MR Fingerprinting and ASL
| Study group | Role | What they receive |
|---|---|---|
| CKD | Chronic Kidney Disease Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1 and T2 value
T1 and T2 value generated by MR Fingerprinting
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639685
- Sponsor's protocol ID
- 2024-SR-102
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Mapping Based on Multi-parametric Functional MRI to Evaluate Renal Functions and Microstructure in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06639685
- Acronym / sponsor ID
- 2024-SR-102
- Conditions
- Chronic Kidney Disease(CKD), MRI
- Keywords
- Chronic Kidney Disease, MR Fingerprinting, ASL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD | – | Diagnostic Test: MRIChronic Kidney Disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with chronic kidney disease by renal biopsy
Key inclusion criteria (1 listed)
- Patients diagnosed with chronic kidney disease (CKD) by renal biopsy
Key exclusion criteria (3 listed)
- Patients with serious underlying diseases
- Patients with MRI incompatible metal implants and contraindications such as claustrophobia
- Patients with imperfect clinical data and pathological data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMR Fingerprinting and ASL | Diagnostic test | CKD |
Primary outcome
T1 and T2 value
Time frame: 3 months
T1 and T2 value generated by MR Fingerprinting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease(CKD) and MRI, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu dong Zhang, MD,PHD (+86 158-0515-1704, zhangyd3895@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T1 and T2 value (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.