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临床试验/NCT04644471
NCT04644471已完成不适用

Comparison Between Ultra-low-dose Computed Tomography and Lung MRI for Morphological Assessment of Lung Disease in Adult Cystic Fibrosis Patients

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2021年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
1
主要终点
Reproducibility of visual score between imaging modalities

研究概览

简要总结

The purpose of this study is to compare the performances of ultra-low dose computed tomography (CT) and lung magnetic resonance imaging (MRI) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose CT

详细描述

Cystic fibrosis (CF) is a recessive autosomal disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that encodes for an epithelial chloride channel involved in ion and fluid transport. CF is the most common inherited disease in Caucasians and disease severity mainly depends on the degree of lung involvement, which can lead to terminal respiratory failure Disease monitoring of CF-related lung disease rely on functional assessment and complimentary morphological assessment. Conventional low-dose chest computed tomography (CT) is currently the gold standard for the morphological assessment of CF-related lung disease but ultra-low dose chest CT and high-resolution magnetic resonance imaging (MRI) of the lung using UTE sequences have been recently developed and allow important radiation reduction of radiation dose exposure. However the performances of these 2 competing imaging methods remains to be compared.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Age ≥ 18 year-old
  • Diagnosis of cystic fibrosis provided by genetic and swear test
  • Chest CT acquisition performed as part of the standard follow-up
  • Patient with social security or health insurance
  • Informed consent

排除标准

  • MRI contraindication
  • Orthopnea
  • Inability to hold breath for 17 seconds
  • No spirometry planned the same day
  • Lung transplant patient

结局指标

主要结局

Reproducibility of visual score between imaging modalities

时间窗: 1 day

Reproducibility disease severity measured by the Helbich scoring system with conventional CT as gold standard

次要结局

  • Correlation between visual scores and pulmonary function(1 day)
  • Intra and interobserver reproducibility of visual scores(1 day)
  • Correlation between air trapping at MRI and pulmonary function test(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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