<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/NCT02977663</url>
  </required_header>
  <id_info>
    <org_study_id>K160701</org_study_id>
    <secondary_id>ANSM</secondary_id>
    <nct_id>NCT02977663</nct_id>
  </id_info>
  <brief_title>Imaging Multiparametric/Multimodality for Lungcancer</brief_title>
  <acronym>IRMomics</acronym>
  <official_title>Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General Electric</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and&#xD;
           molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic&#xD;
           Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor&#xD;
           Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and&#xD;
           follow-up informations (Response to first-line treatment (Response Evaluation Criteria&#xD;
           in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).&#xD;
&#xD;
        2. To propose a simple severity scoring system based on tumor features such as size,&#xD;
           doubling time (if available), location, amount of enhancement and necrosis. Such&#xD;
           approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images&#xD;
           (VASARI)) but is not available for the lung. The objective is to do better than the&#xD;
           Tumor Node Metastasis (TNM) staging.&#xD;
&#xD;
        3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer&#xD;
           evaluation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-free survival of patients with lungcancer</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients by histologic subtypes</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients by mutational profile</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with metastases</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with brain metastases</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of metastases by patient</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))</measure>
    <time_frame>3 months, 1 year, 2 years and 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Lungcancer</condition>
  <arm_group>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Thoracic Magnetic Resonance Imaging (MRI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Chest MRI during the MRI cerebral&#xD;
2 tubes of blood taken during the medical visit</description>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years&#xD;
&#xD;
          -  High suspicion of lungcancer confirmed&#xD;
&#xD;
          -  Tumor &gt; 2 cm&#xD;
&#xD;
          -  Incomplete cerebral staging or not yet realized in the initial consultation of&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lungcancer medical history&#xD;
&#xD;
          -  During Pregnancy&#xD;
&#xD;
          -  Contraindications to MRI&#xD;
&#xD;
          -  Patient not able to understand the information of the protocol, taking into account&#xD;
             the state of the brain&#xD;
&#xD;
          -  Patient unable to keep lying in MRI the necessary time&#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_contact>
    <last_name>Sabine Helfen</last_name>
    <phone>33148957732</phone>
    <email>sabine.helfen@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>BRILLET</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02977663
org study id: K160701
secondary id: ANSM
nct id: NCT02977663
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and
           molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic
           Acid (DNA) from serum biobank…), staging of the cancer (according to the new 2016 Tumor
           Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and
           follow-up informations (Response to first-line treatment (Response Evaluation Criteria
           in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).

        2. To propose a simple severity scoring system based on tumor features such as size,
           doubling time (if available), location, amount of enhancement and necrosis. Such
           approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images
           (VASARI)) but is not available for the lung. The objective is to do better than the
           Tumor Node Metastasis (TNM) staging.

        3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer
           evaluation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Event-free survival of patients with lungcancer
time frame: 3 years
measure: Overall survival
time frame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients by histologic subtypes
time frame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients by mutational profile
time frame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients with metastases
time frame: 3 months, 1 year, 2 years and 3 years
measure: Number of patients with brain metastases
time frame: 3 months, 1 year, 2 years and 3 years
measure: Number of metastases by patient
time frame: 3 months, 1 year, 2 years and 3 years
measure: Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))
time frame: 3 months, 1 year, 2 years and 3 years
arm group label: Magnetic Resonance Imaging (MRI)
arm group type: Other
description: Thoracic Magnetic Resonance Imaging (MRI)
intervention type: Other
intervention name: Magnetic Resonance Imaging (MRI)
description: Chest MRI during the MRI cerebral
2 tubes of blood taken during the medical visit
arm group label: Magnetic Resonance Imaging (MRI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sabine Helfen
phone: 33148957732
email: sabine.helfen@aphp.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No