<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265366</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/12</org_study_id>
    <nct_id>NCT03265366</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses</brief_title>
  <acronym>ABPA-MR</acronym>
  <official_title>Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the concordance between chest computerized tomography-scan&#xD;
      (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen&#xD;
      in Allergic BronchoPulmonary Aspergillosis (ABPA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ABPA is responsible for pulmonary exacerbations in chronic bronchial diseases. The&#xD;
      treatment of ABPA consists in systemic corticosteroids and anti fungal therapy, which can&#xD;
      have severe side effects. The diagnosis is difficult, based on several but non-specific&#xD;
      characteristics. One of the radiologic abnormalities on CTscan could be more specific : high&#xD;
      attenuation in impacted mucus, but this sign is found in about 30% of cases. Recent articles&#xD;
      and investigators experience seem to demonstrate that MRI could provide an interesting tool&#xD;
      for ABPA diagnosis, studying the signal of bronchial impactions. The aim of the study is to&#xD;
      describe the MRI characteristics of patients with ABPA and compare the results with those&#xD;
      obtained by CTscan, and in order to determine if there is a specific signal of impaction in&#xD;
      ABPA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Actual">January 24, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)</measure>
    <time_frame>Day 0</time_frame>
    <description>Measured by a kappa test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Allergic Bronchopulmonary Aspergilloses</condition>
  <arm_group>
    <arm_group_label>ABPA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 patients with ABPA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe asthma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 patients with severe asthma</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.</description>
    <arm_group_label>ABPA</arm_group_label>
    <arm_group_label>Severe asthma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT scan (standard reference)</intervention_name>
    <description>It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.</description>
    <arm_group_label>ABPA</arm_group_label>
    <arm_group_label>Severe asthma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  study patients have a diagnosis of ABPA&#xD;
&#xD;
          -  control patients have severe asthma&#xD;
&#xD;
          -  All the patients are ≥ 18 years old, have social security care, signature of consent&#xD;
             form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cystic fibrosis&#xD;
&#xD;
          -  other type of aspergilloses&#xD;
&#xD;
          -  contraindication for MRI&#xD;
&#xD;
          -  woman without effective contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie MACEY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrashort echo time magnetic resonance imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
    <mesh_term>Pulmonary Aspergillosis</mesh_term>
    <mesh_term>Aspergillosis, Allergic Bronchopulmonary</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265366
org study id: CHUBX 2016/12
nct id: NCT03265366
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare the concordance between chest computerized tomography-scan
      (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen
      in Allergic BronchoPulmonary Aspergillosis (ABPA).
The ABPA is responsible for pulmonary exacerbations in chronic bronchial diseases. The
      treatment of ABPA consists in systemic corticosteroids and anti fungal therapy, which can
      have severe side effects. The diagnosis is difficult, based on several but non-specific
      characteristics. One of the radiologic abnormalities on CTscan could be more specific : high
      attenuation in impacted mucus, but this sign is found in about 30% of cases. Recent articles
      and investigators experience seem to demonstrate that MRI could provide an interesting tool
      for ABPA diagnosis, studying the signal of bronchial impactions. The aim of the study is to
      describe the MRI characteristics of patients with ABPA and compare the results with those
      obtained by CTscan, and in order to determine if there is a specific signal of impaction in
      ABPA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)
time frame: Day 0
description: Measured by a kappa test
arm group label: ABPA
arm group type: Experimental
description: 15 patients with ABPA
arm group label: Severe asthma
arm group type: Active Comparator
description: 12 patients with severe asthma
intervention type: Device
intervention name: MRI
description: It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.
arm group label: ABPA
arm group label: Severe asthma
intervention type: Device
intervention name: CT scan (standard reference)
description: It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
arm group label: ABPA
arm group label: Severe asthma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie MACEY, MD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Aspergillosis
mesh term: Pulmonary Aspergillosis
mesh term: Aspergillosis, Allergic Bronchopulmonary