- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089346
Assessment of Bronchial Thickness Using MRI in Asthma (ASTHMAGRI)
June 5, 2026 updated by: University Hospital, Bordeaux
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
Completed
Conditions
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 (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pessac, France, 33600
- Bordeaux University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
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.
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
Time Frame: Day 1
|
Measurement of quantify bronchial thickness
|
Day 1
|
|
Evaluation of the thickness of bronchial wall by CT
Time Frame: Day 1
|
Measurement of quantify bronchial thickness
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mesure of Pulmonary function
Time Frame: Day 0
|
Pulmonary function test
|
Day 0
|
|
Asthma severity according to GINA 2016
Time Frame: Day 0
|
Asthma severity according to GINA 2016
|
Day 0
|
|
Presence of bronchiectasis
Time Frame: Day 0
|
Observation on the images
|
Day 0
|
|
Presence of mucoid impaction
Time Frame: Day 0
|
Observation on the images
|
Day 0
|
|
Presence of nodule
Time Frame: Day 0
|
Observation on the images
|
Day 0
|
|
Presence of focal condensation
Time Frame: Day 0
|
Observation on the images
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrick BERGER, MD, PhD, University Hospital, Bordeaux
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2017
Primary Completion (Actual)
June 20, 2018
Study Completion (Actual)
June 20, 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 9, 2026
Last Update Submitted That Met QC Criteria
June 5, 2026
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Asthma
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Radiography
- Image Interpretation, Computer-Assisted
- Radiographic Image Enhancement
- Image Enhancement
- Photography
- Tomography, X-Ray
- Magnetic Resonance Imaging
- Tomography, X-Ray Computed
Other Study ID Numbers
- CHUBX2016/13
- 2016-A01390-51 (Other Identifier: ANSM)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Meyer Children's Hospital IRCCSRecruitingAsthma in Children | Asthma Acute | Asthma Crisis | Asthma ChildhoodItaly
-
Tel-Aviv Sourasky Medical CenterThe Dalia and Eli Hurvitz Foundation GrantNot yet recruitingAsthma Attack | Asthma AcuteIsrael
-
University of PittsburghNational Institute of Environmental Health Sciences (NIEHS)RecruitingAsthma Exacerbation | Childhood Asthma | Air Pollution, Risk Reduction Behaviors | Asthma ControlUnited States
-
Vanderbilt University Medical CenterWithdrawnAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Columbia UniversityChildren's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... and other collaboratorsNot yet recruitingAcute Asthma | Pediatric Asthma | Non-invasive Positive Pressure Ventilation | BiPAPUnited States
-
SingHealth PolyclinicsRecruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicSingapore
-
Johann Wolfgang Goethe University HospitalCompleted
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingPersistent Asthma | Asthma (Diagnosis) | Moderate Asthma ExacerbationUnited States
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruiting
Clinical Trials on Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE)
-
Roman GuggenbergerCompletedBone Diseases | Bone AnatomySwitzerland
-
The Hospital for Sick ChildrenNot yet recruiting
-
Mayo ClinicCompleted
-
Beth Israel Deaconess Medical CenterDana-Farber Cancer Institute; American Heart AssociationCompleted
-
Bristol-Myers SquibbPfizerCompletedThrombosisArgentina, United States, Germany, Mexico, Canada, Netherlands, Brazil, Austria, United Kingdom
-
OHSU Knight Cancer InstituteUnited States Department of Defense; Oregon Health and Science University; Portland...Completed
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedPulmonary Arterial Hypertension (PAH)
-
Norwegian University of Science and TechnologySt. Olavs HospitalActive, not recruitingHeart Diseases | Schizophrenia | Heart; Functional DisturbanceNorway
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy SubjectUnited States
-
University of CincinnatiActive, not recruitingProstate CancerUnited States