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临床试验/NCT05682053
NCT05682053已完成不适用

Multiparametric MRI Imaging of Medullary Sponge Kidney

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Comparaison of R2* values measured by BOLD MRI beetween medullary sponge kidney patients and controls.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

patients with medullary sponge kidney

Other

Patients with medullary sponge kidney attending medical consultation

干预措施: Multiparametic MRI (Diagnostic Test)

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

Other

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

干预措施: Multiparametic MRI (Diagnostic Test)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Comparaison of ADC value measured by diffusion-weighted MRI beetween medullary sponge kidney patients and controls.(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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