Clinical trial NCT03089346: Assessment of Bronchial Thickness Using MRI in Asthma
Official title: Assessment of Bronchial Thickness Using MRI in Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Imaging
Bronchial Remodeling
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 30
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: Bronchial remodeling is a major pathological feature of asthma. Non-invasive assessment of this bronchial remodeling is a crucial issue for asthma patients' follow-up. Currently, computed tomography (CT) is the method of reference to evaluate and quantify bronchial thickness but it remains unable to differentiate bronchial inflammation from remodelling and is a radiation-based technique. Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate bronchial thickness in asthma patients using CT and MRI-UTE, and to test the agreement between both techniques.

Detailed description: Asthma is a major public health problem, pathologically characterized by bronchial remodeling that leads to thickening of the bronchial wall. Computed tomography (CT) is the method of reference to quantify bronchial thickness but involves ionizing radiation, thus limiting the possibility of frequent and long-term follow-up. Magnetic Resonance Imaging (MRI) is a non-ionizing 3D imaging technique. However, lung MRI is technically challenging and is not currently used in routine practice. Indeed, both low proton density and susceptibility effects lead to a very low signal intensity derived from lung parenchyma. Recently, pulse sequences with Ultrashort Echo Time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signals from the lung parenchyma. We aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in asthma in order to assess bronchial thickness. Thirty patients with asthma including 10 patients with severe asthma will be enrolled in this study. All participants will benefit from CT and MRI. Our strategy will consist in quantifying bronchial thickness using MRI and CT in those patients, testing for correlations between MRI and CT measurements and assessing the reproducibility of bronchial thickness assessment using MRI. Our objective is to demonstrate that MRI-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying bronchial thickness.

Eligibility criteria: Inclusion Criteria:

* Male or female aged more than 18 years.
* Patients with diagnosis of asthma according to 2016 "Global Strategy for Asthma Management and Prevention (GINA)" definition
* Pulmonary Function Testings (PFTs) should be available within a maximum of 30 days before inclusion.
* With a written informed consent.

Exclusion Criteria:

* Subjects without any social security or health insurance.
* History of chronic obstructive pulmonary disease, lung fibrosis, pulmonary hypertension, lung cancer or cystic fibrosis.
* Pregnancy or breastfeeding women.
* MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia, waistline circumference over 200 cm.

Primary outcomes:
measure: Evaluation of the thickness of bronchial wall by MRI
timeFrame: Day 1
measure: Evaluation of the thickness of bronchial wall by CT
timeFrame: Day 1
Secondary outcomes:
measure: Mesure of Pulmonary function
timeFrame: Day 0
measure: Asthma severity according to GINA 2016
timeFrame: Day 0
measure: Presence of bronchiectasis
timeFrame: Day 0
measure: Presence of mucoid impaction
timeFrame: Day 0
measure: Presence of nodule
timeFrame: Day 0
measure: Presence of focal condensation
timeFrame: Day 0
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Patrick BERGER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: