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Clinical Trials/NCT04644471
NCT04644471
Completed
Not Applicable

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 site in 1 country185 target enrollmentAugust 5, 2021
ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
185
Locations
1
Primary Endpoint
Reproducibility of visual score between imaging modalities
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2021
End Date
July 25, 2024
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Reproducibility of visual score between imaging modalities

Time Frame: 1 day

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

Secondary Outcomes

  • 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)

Study Sites (1)

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