Assessment of Bronchial Thickness Using MRI in Asthma (ASTHMAGRI)

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE); Diagnostic test: Computed tomography (CT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Recruiting
    • Bordeaux University Hospital
    • Sub-Investigator: Gael DOURNES, MD
    • Sub-Investigator: François LAURENT, MD, PhD
    • Sub-Investigator: Pierre-Olivier GIRODET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Asthma; Patients with diagnosis of asthma according to 2016 "Global Strategy for Asthma Management and Prevention (GINA)" definition

Diagnostic test: Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE); Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) pulse sequences on a 1.5T magnet (Avanto dot, Siemens) with 3D reconstruction of the bronchial tree using Neko-MR software in asthma in order to assess bronchial thickness.; Diagnostic test: Computed tomography (CT); Computed tomography (CT) on a Definition 64 (Siemens) with 3D reconstruction of the bronchial tree using Neko-3D software in asthma in order to assess bronchial thickness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the thickness of bronchial wall by MRI	Measurement of quantify bronchial thickness	Day 1
Evaluation of the thickness of bronchial wall by CT	Measurement of quantify bronchial thickness	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesure of Pulmonary function	Pulmonary function test	Day 0
Asthma severity according to GINA 2016	Asthma severity according to GINA 2016	Day 0
Presence of bronchiectasis	Observation on the images	Day 0
Presence of mucoid impaction	Observation on the images	Day 0
Presence of nodule	Observation on the images	Day 0
Presence of focal condensation	Observation on the images	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Imaging; Bronchial Remodeling
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CHUBX2016/13

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