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Completed

NCT Number: NCT04644471

Comparison Between Ultra-low-dose Computed Tomography and Lung MRI in Cystic Fibrosis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CT scanner

Diagnostic Test

1 conventional low dose inspiratory acquisition and 1 ultra-low-dose inspiratory acquisition

Lung MRI

Diagnostic Test

3 UTE sequences (free breathing, inspiratory and expiratory) and 1 T2 sequence

Primary outcomes

  1. 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

  1. Intra and interobserver reproducibility of visual scores

    Time frame: 1 day

    Intra and interobserver reproducibility of the Helbich score for each imaging modality

  2. Correlation between visual scores and pulmonary function

    Time frame: 1 day

    Correlation between the Helbich score for each imaging modality and forced expiratory volume in 1 second (FEV1)

  3. Correlation between air trapping at MRI and pulmonary function test

    Time frame: 1 day

    Correlation between air trapping, measured by comparing inspiratory to expiratory MRI images, and forced expiratory volume at one second (FEV1)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: UBD-IRM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2020
Registry last updated
Feb 13, 2026

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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