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

NCT ID: NCT04644471

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2024-07-25

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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CT scanner

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

Intervention Type DIAGNOSTIC_TEST

Lung MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Pierre REVEL, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Cochin hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 25768672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26843010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31051201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30835186 (View on PubMed)

Other Identifiers

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2019-A02078-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP190061

Identifier Type: -

Identifier Source: org_study_id

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