- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05682053
Multiparametric Magnetic Resonance Imaging (MRI) in Medullary Sponge Kidney (MICARI)
Multiparametric MRI Imaging of Medullary Sponge Kidney
Background :
Medullary sponge kidney disease is a congenital disorder caracterised by tubular ectasia and cystic dilatation of the collecting ducts in the pericalyceal region of the renal pyramids, which can lead to nephrolithiasis and frequently associated with impaired tubular function such as distal renal tubular acidosis.
The disease knowledge is limited, especially about origin, diagnosis, and physiopathology of the disease.
The disease is associated with impaired tubular function such as distal renal tubular acidosis, hypocitraturia, hypercalciuria, which suggest altered kidney medulla function.
Multiparametric MRI may provide further informations about the physiopathology and help in earlier diagnosis of the medullary sponge kidney.
Objective :
The aim of this study is to test the hypothesis that early kidney medulla function alteration in medullary sponge kidney can be detected and characterised with multiparametric MRI. We are expecting to see in medullary sponge kidney a decreased oxygenation content in BOLD MRI (Blood oxygenation level dependent magnetic resonance imaging), and decreased ADC (Apparent diffusion coefficient) value in the medulla.
Design :
A monocentric prospective case/control study will be conducted in adults with medullary sponge kidney. Controls are adults patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration.
After a screening visit, patients included will be evaluated on one day with lithiasis assessment and measurement of glomerular filtration (Urinary collection of the last 24 hours, Urine sample, Blood sample) and they will perform multiparametric magnetic resonance imaging of the kidneys.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69003
- Hôpital Edouard Herriot
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- medullary sponge kidney attending medical consultation
- Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone
- consent signed
- effective contraceptive method for women
- affiliated to social insurance scheme
Exclusion Criteria:
- kidney transplant
- polycystic kidney diseases
- Chronic kidney disease (GFR < 60 mL/min/1,73m² )
- MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible)
- Weight> 130 kg
- pregnancy
- legal protection measure (guardianship, curatorship)
- Deprived of liberty by a judicial or administrative decision
- subject participating in another research that may interfere with the research and including an exclusion period still in progress at inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: patients with medullary sponge kidney
Patients with medullary sponge kidney attending medical consultation
|
patients will have a Multiparametric MRI
|
|
Other: Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone
Patients with glomerular filtration rate > 60 mL/min/1.73m2
without kidney stone attending a renal exploration.
|
patients will have a Multiparametric MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls.
Time Frame: Day 0
|
Comparaison of R2* values measured by BOLD MRI between medullary sponge kidney patients and controls. R2* is related to the level of tissue deoxyhemoglobin, which reflect tissue oxygenation. Increases in its outcome measure R2* (transverse relaxation rate expressed as per second) correspond to higher deoxyhaemoglobin concentrations and suggest lower oxygenation, whereas decreases in R2* indicate higher oxygenation. |
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.
Time Frame: Day 0
|
Diffusion-weighted magnetic resonance imaging (DWI) is a non-invasive method sensitive to local water motion in the tissue, which is particularly sensitive to alterations in the renal interstitium, e.g. during renal fibrosis
|
Day 0
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparaison of T1 Value measured by T1 mapping MRI between medullary sponge kidney patients and controls.
Time Frame: Day 0
|
T1 mapping is a MRI sequence to estimate renal fibrosis
|
Day 0
|
|
Comparaison of T2 Value measured by T2 mapping MRI between medullary sponge kidney patients and controls.
Time Frame: Day 0
|
T2 mapping is a MRI sequence to estimate renal alteration
|
Day 0
|
|
In medullary sponge kidney patients, evaluation of the association between kidney function and : - ADC value measured by diffusion-weighted MRI - T1 Value measured by T1 mapping MRI - T2 Value measured by T2 mapping MRI
Time Frame: Day 0
|
Day 0
|
|
|
In medullary sponge kidney patients, evaluation of the association between 24 hours calciuria and : - ADC value measured by diffusion-weighted MRI - T1 Value measured by T1 mapping MRI - T2 Value measured by T2 mapping MRI
Time Frame: Day 0
|
exploration if medulla modifications can lead to hypercalciuria
|
Day 0
|
|
In medullary sponge kidney patients, evaluation of the association between 24 hours citraturia and : - ADC value measured by diffusion-weighted MRI - T1 Value measured by T1 mapping MRI - T2 Value measured by T2 mapping MRI
Time Frame: Day 0
|
exploration if medulla modifications can lead to hypocitraturia
|
Day 0
|
|
In medullary sponge kidney patients, evaluation of the association between urine pH and : - ADC value measured by diffusion-weighted MRI - T1 Value measured by T1 mapping MRI - T2 Value measured by T2 mapping MRI
Time Frame: Day 0
|
exploration if medulla modifications is correlated to urine pH modifications
|
Day 0
|
|
In medullary sponge kidney patients, evaluation of the association between maximum urinary osmolarity and : - ADC value measured by diffusion-weighted MRI - T1 Value measured by T1 mapping MRI -T2 Value measured by T2 mapping MRI
Time Frame: Day 0
|
exploration if medulla modifications can lead to a decrease of renal concentration ability
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Kidney Diseases, Cystic
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Medullary Sponge Kidney
Other Study ID Numbers
- 69HCL22_0366
- 2022-A01467-36 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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