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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Medullary Sponge Kidney

Treatments

Diagnostic Test: Multiparametic MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05682053
69HCL22_0366
2022-A01467-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No 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 that may interfere with the research and including an exclusion period still in progress at inclusion

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups

patients with medullary sponge kidney
Other group
Description:
Patients with medullary sponge kidney attending medical consultation
Treatment:
Diagnostic Test: Multiparametic MRI
Patients with glomerular filtration rate > 60 mL/min/1.73m2 without kidney stone
Other group
Description:
Patients with glomerular filtration rate \> 60 mL/min/1.73m2 without kidney stone attending a renal exploration.
Treatment:
Diagnostic Test: Multiparametic MRI

Trial contacts and locations

1

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Central trial contact

Sandrine LEMOINE, Pr; Laurence Derain, Pr

Data sourced from clinicaltrials.gov

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