<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/NCT03281031</url>
  </required_header>
  <id_info>
    <org_study_id>UF9803</org_study_id>
    <secondary_id>2017-A00725-48</secondary_id>
    <nct_id>NCT03281031</nct_id>
  </id_info>
  <brief_title>MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women</brief_title>
  <acronym>IRMADA</acronym>
  <official_title>Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Direction Générale de l'Offre de Soins</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective :&#xD;
&#xD;
      To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to&#xD;
      Computed Tomography (CT) as a second intention imaging modality in young women with acute non&#xD;
      traumatic abdominopelvic pain and non contributive ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods :&#xD;
&#xD;
      Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the&#xD;
      emergency Physician or gynaecologist after a non contributive ultrasonography will be&#xD;
      included.&#xD;
&#xD;
      After obtaining informed consent, all patients will undergo standard CT followed by an&#xD;
      additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.&#xD;
&#xD;
      The gold standard or reference diagnosis will be established in consensus by an expert panel&#xD;
      at 3 months follow up using a standardized diagnosis form.&#xD;
&#xD;
      A retrospective reading will be performed independently for CT and MRI by radiologists&#xD;
      blinded to the reference diagnosis, using the same standardized diagnosis form.&#xD;
&#xD;
      CT and MRI accuracies will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performances comparison between CT and MRI</measure>
    <time_frame>3 months</time_frame>
    <description>Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive</measure>
    <time_frame>3 months</time_frame>
    <description>Diagnostic performances (sensitivity, specificity and predictive values) of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive (strategy built retrospectively)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performances of unenhanced MRI sequences versus complete MRI examination</measure>
    <time_frame>3 months</time_frame>
    <description>Diagnostic performances (sensitivity, specificity and predictive values) of unenhanced MRI sequences versus complete MRI examination (including both unenhanced and enhanced sequences)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-reader agreement for MRI and CT diagnoses</measure>
    <time_frame>3 months</time_frame>
    <description>Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">347</enrollment>
  <condition>Acute Abdominal Pain</condition>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Additional MRI Examination</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm, all patient will undergo CT followed by additional MRI examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Additional MRI Examination</intervention_name>
    <description>MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results</description>
    <arm_group_label>Additional MRI Examination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-40 years old&#xD;
&#xD;
          -  Women referred to CT following a non contributive ultrasonography&#xD;
&#xD;
          -  Women with acute non traumatic abdominopelvic pain (less than 5 day-duration)&#xD;
&#xD;
          -  Women with informed consent&#xD;
&#xD;
          -  Women with affiliation to health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who underwent abdominopelvic surgery in the previous month&#xD;
&#xD;
          -  Suspicion of vital emergency such as shock preventing any delayed management caused by&#xD;
             MRI examination&#xD;
&#xD;
          -  Contra-indication to MRI, including pace maker, ferro-magnetic material, foreign&#xD;
             bodies with risk of mobilization during MRI examination&#xD;
&#xD;
          -  Women yet included in the study or included in another study&#xD;
&#xD;
          -  Women pregnant (positive beta chorionic gonadotrophic hormone testing) or&#xD;
             breastfeeding&#xD;
&#xD;
          -  Women unable to undergo informed consent (vulnerable or protected by law)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid MILLET, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ingrid MILLET, MD, PhD</last_name>
    <phone>0467338817</phone>
    <email>i-millet@chu-montpellier.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrice TAOUREL, MD, PhD</last_name>
    <phone>0467338610</phone>
    <email>p-taourel@chu-montpellier.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Departement of Medical Imaging</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingrid MILLET, MD, PhD</last_name>
      <phone>0467338817</phone>
      <email>i-millet@chu-montpellier.fr</email>
    </contact>
    <contact_backup>
      <last_name>Patrice TAOUREL, MD, PhD</last_name>
      <phone>0467338610</phone>
      <email>p-taourel@chu-montpellier.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Acute abdominal pain</keyword>
  <keyword>Pelvic pain</keyword>
  <keyword>Diagnostic performance</keyword>
  <keyword>Young women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Pain</mesh_term>
    <mesh_term>Abdominal Pain</mesh_term>
    <mesh_term>Abdomen, Acute</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/NCT03281031
org study id: UF9803
secondary id: 2017-A00725-48
nct id: NCT03281031
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective :

      To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to
      Computed Tomography (CT) as a second intention imaging modality in young women with acute non
      traumatic abdominopelvic pain and non contributive ultrasonography.
Methods :

      Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the
      emergency Physician or gynaecologist after a non contributive ultrasonography will be
      included.

      After obtaining informed consent, all patients will undergo standard CT followed by an
      additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.

      The gold standard or reference diagnosis will be established in consensus by an expert panel
      at 3 months follow up using a standardized diagnosis form.

      A retrospective reading will be performed independently for CT and MRI by radiologists
      blinded to the reference diagnosis, using the same standardized diagnosis form.

      CT and MRI accuracies will be compared.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic performances comparison between CT and MRI
time frame: 3 months
description: Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
measure: Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive
time frame: 3 months
description: Diagnostic performances (sensitivity, specificity and predictive values) of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive (strategy built retrospectively)
measure: Diagnostic performances of unenhanced MRI sequences versus complete MRI examination
time frame: 3 months
description: Diagnostic performances (sensitivity, specificity and predictive values) of unenhanced MRI sequences versus complete MRI examination (including both unenhanced and enhanced sequences)
measure: Inter-reader agreement for MRI and CT diagnoses
time frame: 3 months
description: Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)
arm group label: Additional MRI Examination
arm group type: Other
description: Single arm, all patient will undergo CT followed by additional MRI examination
intervention type: Procedure
intervention name: Additional MRI Examination
description: MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results
arm group label: Additional MRI Examination
criteria: 
gender: Female
gender based: Yes
gender description: Women
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ingrid MILLET, MD, PhD
role: Principal Investigator
affiliation: Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
last name: Ingrid MILLET, MD, PhD
phone: 0467338817
email: i-millet@chu-montpellier.fr
last name: Patrice TAOUREL, MD, PhD
phone: 0467338610
email: p-taourel@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Pelvic Pain
mesh term: Abdominal Pain
mesh term: Abdomen, Acute