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NCT Number: NCT05682053

Multiparametric Magnetic Resonance Imaging (MRI) in 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.

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Key information

Conditions

Medullary Sponge Kidney Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiparametic MRI

Diagnostic Test

patients will have a Multiparametric MRI

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Multiparametric MRI Imaging of Medullary Sponge Kidney

Acronym: MICARI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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