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Comparison Between Ultra-low-dose Computed Tomography and Lung MRI in Cystic Fibrosis (UBD-IRM)

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ClinicalTrials.gov Identifier: NCT04644471
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Diagnostic Test: CT scanner Diagnostic Test: Lung MRI Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison Between Ultra-low-dose Computed Tomography and Lung MRI for Morphological Assessment of Lung Disease in Adult Cystic Fibrosis Patients
Actual Study Start Date : August 5, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Diagnostic Test: CT scanner
    1 conventional low dose inspiratory acquisition and 1 ultra-low-dose inspiratory acquisition
  • Diagnostic Test: Lung MRI
    3 UTE sequences (free breathing, inspiratory and expiratory) and 1 T2 sequence

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644471


Contacts
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Contact: Guillaume CHASSAGNON, PhD +33 1 58 41 53 66 guillaume.chassagnon@aphp.fr
Contact: Adèle BELLINO +33 158411195 adele.bellino@aphp.fr

Locations
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France
Cochin hospital Recruiting
Paris, France, 75014
Contact: Guillaume CHASSAGNON, PhD    +33 1 58 41 53 66    guillaume.chassagnon@aphp.fr   
Contact: Adèle BELLINO    + 33 158411195    adele.bellino@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Marie-Pierre REVEL, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04644471    
Other Study ID Numbers: APHP190061
2019-A02078-49 ( Registry Identifier: ID-RCB )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Magnetic resonance imaging
Multidetector computed tomography
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases