Assessment of Bronchial Thickness Using MRI in Asthma (ASTHMAGRI)
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE)
Computed tomography (CT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring Imaging, Bronchial Remodeling
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.
Sites / Locations
- Bordeaux University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Asthma
Arm Description
Patients with diagnosis of asthma according to 2016 "Global Strategy for Asthma Management and Prevention (GINA)" definition
Outcomes
Primary Outcome Measures
Evaluation of the thickness of bronchial wall by MRI
Measurement of quantify bronchial thickness
Evaluation of the thickness of bronchial wall by CT
Measurement of quantify bronchial thickness
Secondary Outcome Measures
Mesure of Pulmonary function
Pulmonary function test
Asthma severity according to GINA 2016
Asthma severity according to GINA 2016
Presence of bronchiectasis
Observation on the images
Presence of mucoid impaction
Observation on the images
Presence of nodule
Observation on the images
Presence of focal condensation
Observation on the images
Full Information
NCT ID
NCT03089346
First Posted
March 17, 2017
Last Updated
June 26, 2018
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03089346
Brief Title
Assessment of Bronchial Thickness Using MRI in Asthma
Acronym
ASTHMAGRI
Official Title
Assessment of Bronchial Thickness Using MRI in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Imaging, Bronchial Remodeling
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Asthma
Arm Type
Other
Arm Description
Patients with diagnosis of asthma according to 2016 "Global Strategy for Asthma Management and Prevention (GINA)" definition
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Computed tomography (CT)
Intervention Description
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 Measure Information:
Title
Evaluation of the thickness of bronchial wall by MRI
Description
Measurement of quantify bronchial thickness
Time Frame
Day 1
Title
Evaluation of the thickness of bronchial wall by CT
Description
Measurement of quantify bronchial thickness
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Mesure of Pulmonary function
Description
Pulmonary function test
Time Frame
Day 0
Title
Asthma severity according to GINA 2016
Description
Asthma severity according to GINA 2016
Time Frame
Day 0
Title
Presence of bronchiectasis
Description
Observation on the images
Time Frame
Day 0
Title
Presence of mucoid impaction
Description
Observation on the images
Time Frame
Day 0
Title
Presence of nodule
Description
Observation on the images
Time Frame
Day 0
Title
Presence of focal condensation
Description
Observation on the images
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick BERGER, MD, PhD
Phone
+335 57 65 65 13
Email
patrick.berger@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Olivier GIRODET, MD
Phone
+335 57 62 31 94
Email
pierre-olivier.girodet@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick BERGER, MD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick BERGER, MD, PhD
Phone
+335 57 65 65 13
Email
patrick.berger@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Gael DOURNES, MD
First Name & Middle Initial & Last Name & Degree
François LAURENT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pierre-Olivier GIRODET, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Bronchial Thickness Using MRI in Asthma
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