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

Cystic Fibrosis Clinical Trial

— UBD-IRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644471
• Other study ID #: APHP190061
• Secondary ID: 2019-A02078-49
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Guillaume CHASSAGNON, PhD
• Phone: +33 1 58 41 53 66
• Email: guillaume.chassagnon[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
France	Cochin hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. Erratum In: Radiology. 2016 Apr;279(1):328. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of visual score between imaging modalities	Reproducibility disease severity measured by the Helbich scoring system with conventional CT as gold standard	1 day
Secondary	Intra and interobserver reproducibility of visual scores	Intra and interobserver reproducibility of the Helbich score for each imaging modality	1 day
Secondary	Correlation between visual scores and pulmonary function	Correlation between the Helbich score for each imaging modality and forced expiratory volume in 1 second (FEV1)	1 day
Secondary	Correlation between air trapping at MRI and pulmonary function test	Correlation between air trapping, measured by comparing inspiratory to expiratory MRI images, and forced expiratory volume at one second (FEV1)	1 day