Evaluating bronchial remodeling in children with severe asthma using MRI

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

This study is testing a new MRI method to see if it can safely check for changes in the airways of children with severe asthma without using invasive procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: University Hospital, Bordeaux (Academic / other)
• Locations: 2 sites (Bordeaux and 1 other locations)
• Trial ID: NCT05419622 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess bronchial remodeling in children with severe asthma through 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI). The study will compare bronchial parameters obtained from MRI with those determined by invasive bronchial biopsies using immunohistochemistry. The goal is to establish a non-invasive method for diagnosing bronchial remodeling, which is crucial for understanding and managing severe asthma in pediatric patients. This approach seeks to avoid the risks associated with radiation exposure from traditional imaging techniques like CT scans.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 17 years diagnosed with severe asthma requiring high-dose inhaled corticosteroids and a long-acting bronchodilator.

Not a fit: Patients without a diagnosis of severe asthma or those who do not require bronchial fibroscopy as part of their routine care may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer, non-invasive diagnostic tool for assessing bronchial remodeling in children with severe asthma.

How similar studies have performed: While traditional imaging methods have been used, this novel approach using 3D-UTE MRI for bronchial remodeling in children with severe asthma has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient without affiliation or not benefiting from a social security scheme;
* Patient being in a period of relative exclusion from another protocol;
* 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.

Where this trial is running

Bordeaux and 1 other locations

• CHU de Bordeaux - Explorations Fonctionnelles — Bordeaux, France (Recruiting)
• Centre Hospitalier de Saintonge — Saintes, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Fabien BEAUFILS, MD — University Hospital, Bordeaux
• Study coordinator: Fabien BEAUFILS, MD

Conditions Asthma in Children; asthma; children; serious; magnetic resonance imaging