Assessment of Bronchial Thickness Using MRI in Asthma (ASTHMAGRI)

June 26, 2018 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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Pessac, France, 33600
        • Recruiting
        • Bordeaux University Hospital
        • Sub-Investigator:
          • Gael DOURNES, MD
        • Sub-Investigator:
          • François LAURENT, MD, PhD
        • Sub-Investigator:
          • Pierre-Olivier GIRODET, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX2016/13

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.

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