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Assessment of Bronchial Thickness Using MRI in Asthma (ASTHMAGRI)

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ClinicalTrials.gov Identifier: NCT03089346
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Asthma Diagnostic Test: Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) Diagnostic Test: Computed tomography (CT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Bronchial Thickness Using MRI in Asthma
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Evaluation of the thickness of bronchial wall by MRI [ Time Frame: Day 1 ]
    Measurement of quantify bronchial thickness

  2. Evaluation of the thickness of bronchial wall by CT [ Time Frame: Day 1 ]
    Measurement of quantify bronchial thickness


Secondary Outcome Measures :
  1. Mesure of Pulmonary function [ Time Frame: Day 0 ]
    Pulmonary function test

  2. Asthma severity according to GINA 2016 [ Time Frame: Day 0 ]
    Asthma severity according to GINA 2016

  3. Presence of bronchiectasis [ Time Frame: Day 0 ]
    Observation on the images

  4. Presence of mucoid impaction [ Time Frame: Day 0 ]
    Observation on the images

  5. Presence of nodule [ Time Frame: Day 0 ]
    Observation on the images

  6. Presence of focal condensation [ Time Frame: Day 0 ]
    Observation on the images



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089346


Contacts
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Contact: Patrick BERGER, MD, PhD +335 57 65 65 13 patrick.berger@chu-bordeaux.fr
Contact: Pierre-Olivier GIRODET, MD +335 57 62 31 94 pierre-olivier.girodet@chu-bordeaux.fr

Locations
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France
Bordeaux University Hospital Recruiting
Pessac, France, 33600
Contact: Patrick BERGER, MD, PhD    +335 57 65 65 13    patrick.berger@chu-bordeaux.fr   
Sub-Investigator: Gael DOURNES, MD         
Sub-Investigator: François LAURENT, MD, PhD         
Sub-Investigator: Pierre-Olivier GIRODET, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Patrick BERGER, MD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03089346     History of Changes
Other Study ID Numbers: CHUBX2016/13
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Imaging
Bronchial Remodeling

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases