Clinical trial NCT04644471: Comparison Between Ultra-low-dose Computed Tomography and Lung MRI in Cystic Fibrosis
Official title: Comparison Between Ultra-low-dose Computed Tomography and Lung MRI for Morphological Assessment of Lung Disease in Adult Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Magnetic resonance imaging
Multidetector computed tomography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Reproducibility of visual score between imaging modalities
timeFrame: 1 day
Secondary outcomes:
measure: Intra and interobserver reproducibility of visual scores
timeFrame: 1 day
measure: Correlation between visual scores and pulmonary function
timeFrame: 1 day
measure: Correlation between air trapping at MRI and pulmonary function test
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-Pierre REVEL, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dournes G, Grodzki D, Macey J, Girodet PO, Fayon M, Chateil JF, Montaudon M, Berger P, Laurent F. Quiet Submillimeter MR Imaging of the Lung Is Feasible with a PETRA Sequence at 1.5 T. Radiology. 2015 Jul;276(1):258-65. doi: 10.1148/radiol.15141655. Epub 2015 Mar 13.
citation: Dournes G, Menut F, Macey J, Fayon M, Chateil JF, Salel M, Corneloup O, Montaudon M, Berger P, Laurent F. Lung morphology assessment of cystic fibrosis using MRI with ultra-short echo time at submillimeter spatial resolution. Eur Radiol. 2016 Nov;26(11):3811-3820. doi: 10.1007/s00330-016-4218-5. Epub 2016 Feb 2.
citation: Chassagnon G, Martin C, Ben Hassen W, Freche G, Bennani S, Morel B, Revel MP. High-resolution lung MRI with Ultrashort-TE: 1.5 or 3 Tesla? Magn Reson Imaging. 2019 Sep;61:97-103. doi: 10.1016/j.mri.2019.04.015. Epub 2019 Apr 30.
citation: Chassagnon G, Martin C, Marini R, Vakalopolou M, Regent A, Mouthon L, Paragios N, Revel MP. Use of Elastic Registration in Pulmonary MRI for the Assessment of Pulmonary Fibrosis in Patients with Systemic Sclerosis. Radiology. 2019 May;291(2):487-492. doi: 10.1148/radiol.2019182099. Epub 2019 Mar 5.