Analysis of Bronchial Remodeling Using Resonance Magnetic Imaging in Severe Asthmatic childrEn

NCT05419622 | Unknown

• 1 other identifier: CHUBX 2020/48
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a diagnostic imaging pilot study evaluating performance of 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI) for the diagnosis of bronchial remodeling in children with severe asthma. The primary objective is to compare bronchial parameters measured by 3D-UTE MRI according to the presence or the absence of bronchial remodeling determined on bronchial biopsies using immunohistochemistry, in severe asthmatic children.

Conditions

Asthma in Children

Keywords

asthma; children; serious; magnetic resonance imaging

Outcome Measures

Primary Outcomes (4)

• Measure of Bronchial thickness (BT) in UTE-T1 (in mm)

  Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: \- Bronchial thickness (BT) in UTE-T1 (mm)

  Day 30

• Measure of Signal strength of the bronchial wall (SB) in UTE-T1 (in milliseconds)

  Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: \- Signal intensity of bronchial edema (SE) in T2- Turbo Spin-Echo (TSE) (second)

  Day 30

• Measure of Volume of bronchial edema (VO) in T2-Turbo Spin-Echo (TSE) (in cubic millimeters)

  Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: \- Volume of bronchial edema (VE) in T2-Turbo Spin-Echo (TSE) (mm\^3)

  Day 30

• Measure of Bronchial edema (SO) signal intensity in T2-Turbo Spin-Echo (TSE) (in milliseconds)

  Mean (or median if the distribution is not normal) of the following candidate parameters measured on the 3D-UTE MRI performed either on the average of the 4th bronchial generation or on the only biopsied bronchus obtained at Visit 3: \- Signal intensity of bronchial edema (SE) in T2-Turbo Spin-Echo (TSE) (second)

  Day 30

Secondary Outcomes (8)

• Comparison each measurable values between 2 Physicians evaluated in the principal outcome measures

  Day 30

• Measure of expiratory forced vital capacity (FVC)

  Day 30

• Measure of forced expiratory volume in one second (FEV1)

  Day 30

• Measure length of reticular basement membrane (RBM) completely denuded or covered by a single layer of basal cells with no intact ciliated or goblet cell over total basement membrane length

  Day 30

• Measure of reticular basement membrane thickness (µm)

  Day 30

Study Arms (1)

lung MRI

EXPERIMENTAL

The procedure under study is lung MRI, performed on a 1.5T magnet (AERA dot 1.5T, Siemens), without anesthesia and without injection or inhalation of contrast agent.

Biological: bronchial biopsies

Interventions

bronchial biopsies BIOLOGICAL

This fibroscopy will make it possible to perform 4 bronchial biopsies at the level of the 4th bronchial generation (subsegmental bronchi), using suitable pediatric forceps.

lung MRI

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child from 6 to 17 years old
• Having informed consent signed by the holders of parental authority.
• Having a diagnosis of severe asthma according to the Global Initiative for Asthma (GINA) 2020;
• Asthma: chronic inflammatory disease of the airways, defined mainly by respiratory symptoms such as wheezing, dyspnea, chest tightness and / or cough, which may vary in time and intensity associated with a limitation also varying in the time of expiratory flow.
• Severe asthma: asthma which requires treatment with inhaled corticosteroids in high doses plus a second long-acting bronchodilator type controller, to maintain control of symptoms and / or whose control worsens if this treatment is reduced and / or which remains uncontrolled despite this treatment.
• Having to carry out as part of the current care a functional respiratory exploration;
• Should require as part of the routine care of a bronchial fibroscopy.

You may not qualify if:

• Patient without affiliation or not benefiting from a social security scheme;
• Patient born before 36 weeks of amenorrhea;
• Patient with a documented history of pulmonary fibrosis, primary pulmonary arterial hypertension, cystic fibrosis, pulmonary malformation or chronic viral infections (hepatitis, HIV);
• Patient presenting with an exacerbation of asthma requiring systemic corticosteroids within the previous 4 weeks;
• Patient with any dental, nasopharyngeal or bronchial infection with fever (\> 39 ° C) requiring systemic antibiotics within the previous 4 weeks
• Patient with a contraindication to MRI:
• Abdominal perimeter greater than 200 cm;
• Claustrophobia or inability to lie still for 12 minutes;
• Have a pacemaker or implantable defibrillator, intraocular metallic foreign body, intracranial metal clip, a pre-6000 Starr-Edwards type heart valve prosthesis, or a biomedical device such as an insulin pump or neurostimulator, cochlear implant and metal patch.
• Patient with a contraindication to anesthesia;
• Patient with a contraindication to bronchial fibroscopy following:
• Abnormal hemostasis assessment;
• Subject with cardiac pathology.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

CHU de Bordeaux - Explorations Fonctionnelles

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier de Saintonge

Saintes, 17100, France

NOT YET RECRUITING

Related Publications (5)

• Bara I, Ozier A, Tunon de Lara JM, Marthan R, Berger P. Pathophysiology of bronchial smooth muscle remodelling in asthma. Eur Respir J. 2010 Nov;36(5):1174-84. doi: 10.1183/09031936.00019810.

  PMID: 21037369 RESULT

• Girodet PO, Ozier A, Bara I, Tunon de Lara JM, Marthan R, Berger P. Airway remodeling in asthma: new mechanisms and potential for pharmacological intervention. Pharmacol Ther. 2011 Jun;130(3):325-37. doi: 10.1016/j.pharmthera.2011.02.001. Epub 2011 Feb 17.

  PMID: 21334378 RESULT

• Bossley CJ, Fleming L, Gupta A, Regamey N, Frith J, Oates T, Tsartsali L, Lloyd CM, Bush A, Saglani S. Pediatric severe asthma is characterized by eosinophilia and remodeling without T(H)2 cytokines. J Allergy Clin Immunol. 2012 Apr;129(4):974-82.e13. doi: 10.1016/j.jaci.2012.01.059. Epub 2012 Mar 3.

  PMID: 22385633 RESULT

• Benlala I, Dournes G, Girodet PO, Benkert T, Laurent F, Berger P. Evaluation of bronchial wall thickness in asthma using magnetic resonance imaging. Eur Respir J. 2021 Dec 31;59(1):2100329. doi: 10.1183/13993003.00329-2021. Print 2022 Jan. No abstract available.

  PMID: 34049945 RESULT

• Dournes G, Yazbek J, Benhassen W, Benlala I, Blanchard E, Truchetet ME, Macey J, Berger P, Laurent F. 3D ultrashort echo time MRI of the lung using stack-of-spirals and spherical k-Space coverages: Evaluation in healthy volunteers and parenchymal diseases. J Magn Reson Imaging. 2018 Dec;48(6):1489-1497. doi: 10.1002/jmri.26212. Epub 2018 Sep 11.

  PMID: 30203889 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Fabien BEAUFILS, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien BEAUFILS, MD

CONTACT

+335 56 79 55 86; fabien.beaufils@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Early study to evaluate the diagnostic and diagnostic performances of an imaging sequence, non-randomized, observational, prospective and bicentric.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 15, 2022
• Study Start: June 8, 2023
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)