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Multiparametric Magnetic Resonance Imaging (MRI) in Medullary Sponge Kidney (MICARI)

Primary Purpose

Medullary Sponge Kidney

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiparametic MRI
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Medullary Sponge Kidney focused on measuring medullary sponge kidney, kidney stone, multiparametric MRI, medullary function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 including an exclusion period still in progress at inclusion

Sites / Locations

  • Hôpital Edouard HerriotRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

patients with medullary sponge kidney

Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone

Arm Description

Patients with medullary sponge kidney attending medical consultation

Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration.

Outcomes

Primary Outcome Measures

Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls.
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.

Secondary Outcome Measures

Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.
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

Full Information

First Posted
December 27, 2022
Last Updated
September 13, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05682053
Brief Title
Multiparametric Magnetic Resonance Imaging (MRI) in Medullary Sponge Kidney
Acronym
MICARI
Official Title
Multiparametric MRI Imaging of Medullary Sponge Kidney
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
March 28, 2025 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medullary Sponge Kidney
Keywords
medullary sponge kidney, kidney stone, multiparametric MRI, medullary function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with medullary sponge kidney
Arm Type
Other
Arm Description
Patients with medullary sponge kidney attending medical consultation
Arm Title
Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone
Arm Type
Other
Arm Description
Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone attending a renal exploration.
Intervention Type
Diagnostic Test
Intervention Name(s)
Multiparametic MRI
Intervention Description
patients will have a Multiparametric MRI
Primary Outcome Measure Information:
Title
Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls.
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.
Description
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
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Comparaison of T1 Value measured by T1 mapping MRI between medullary sponge kidney patients and controls.
Description
T1 mapping is a MRI sequence to estimate renal fibrosis
Time Frame
Day 0
Title
Comparaison of T2 Value measured by T2 mapping MRI between medullary sponge kidney patients and controls.
Description
T2 mapping is a MRI sequence to estimate renal alteration
Time Frame
Day 0
Title
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
Title
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
Description
exploration if medulla modifications can lead to hypercalciuria
Time Frame
Day 0
Title
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
Description
exploration if medulla modifications can lead to hypocitraturia
Time Frame
Day 0
Title
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
Description
exploration if medulla modifications is correlated to urine pH modifications
Time Frame
Day 0
Title
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
Description
exploration if medulla modifications can lead to a decrease of renal concentration ability
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 including an exclusion period still in progress at inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine LEMOINE, Pr
Phone
472110252
Ext
+33
Email
sandrine.lemoine01@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Derain, Pr
Phone
472119117
Ext
+33
Email
laurence.dubourg@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine LEMOINE, Pr
Phone
472110252
Ext
+33
Email
sandrine.lemoine01@chu-lyon.fr

12. IPD Sharing Statement

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Multiparametric Magnetic Resonance Imaging (MRI) in Medullary Sponge Kidney

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