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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Diagnostic test: CT scanner; Diagnostic test: Lung MRI

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume CHASSAGNON, PhD; Phone Number: +33 1 58 41 53 66; Email: guillaume.chassagnon@aphp.fr
• Study Contact Backup: Name: Adèle BELLINO; Phone Number: +33 158411195; Email: adele.bellino@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Cochin Hospital
    • Contact: Guillaume CHASSAGNON, PhD; Phone Number: +33 1 58 41 53 66; Email: guillaume.chassagnon@aphp.fr
    • Contact: Adèle BELLINO; Phone Number: + 33 158411195; Email: adele.bellino@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra and interobserver reproducibility of visual scores	Intra and interobserver reproducibility of the Helbich score for each imaging modality	1 day
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Marie-Pierre REVEL, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Multidetector computed tomography
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: APHP190061; 2019-A02078-49 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No