<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/NCT02250755</url>
  </required_header>
  <id_info>
    <org_study_id>2012_27</org_study_id>
    <secondary_id>2012-A01644-39</secondary_id>
    <nct_id>NCT02250755</nct_id>
  </id_info>
  <brief_title>MRI Perfusion on T1 and T2 Brain Lesion(s)</brief_title>
  <acronym>METAPERF</acronym>
  <official_title>Comparison of MRI Sequences T1 and T2 * Cerebral Perfusion to Aid in the Diagnosis and Evaluation of Brain Therapeutic Response With Chemotherapy or Targeted Therapy(s) Lesion(s) in Patients Treated and Followed for a Pulmonary Neoplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study therefore aims to assess current treatment recommended by scientific societies [&#xD;
      6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain&#xD;
      metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg&#xD;
      [ 14 ] . Sequences infusion different from one center to the other made : some use the&#xD;
      infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to&#xD;
      use one or the other of these sequences.&#xD;
&#xD;
      No examination is added for the purposes of protocol. Indications for MRI and the number and&#xD;
      timing of MRI checks under this protocol are consistent with what is done in practice . The&#xD;
      used type of gadolinium and the injected dose will be identical for both sequences infusion .&#xD;
      The assessment shall not in any case the contrast but the interpretation of the sequence&#xD;
      itself. Special procedures monitoring implemented embodiment correspond to the two sequences&#xD;
      instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI&#xD;
      of the first control , in order to compare their effectiveness&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligibility criteria:&#xD;
&#xD;
        -  Major Patients&#xD;
&#xD;
        -  Addressed MRI for initial assessment of brain metastases&#xD;
&#xD;
        -  At a suspicion of one or more brain metastases in the brain scanner routine screening&#xD;
&#xD;
        -  Follow for lung cancer histologically documented&#xD;
&#xD;
        -  In the Thoracic Oncology Service Professor Lafitte (contact: Dr Cortot)&#xD;
&#xD;
        -  To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is&#xD;
           considered&#xD;
&#xD;
        -  Be socially insured&#xD;
&#xD;
      Main Outcomes measures:&#xD;
&#xD;
      Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 *&#xD;
      perfusion during the initial assessment for the diagnosis of maximal tumor response evaluated&#xD;
      at 1 year&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Comparing different parameters evaluated in T1 and T2 * perfusion</measure>
    <time_frame>3 years</time_frame>
    <description>Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 * perfusion during the initial assessment for the diagnosis of maximal tumor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation tumor response</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of the area under the ROC curve of the change in the first control of the various parameters measured in T1 and T2 * infusion, for the diagnosis of maximum tumor response evaluated at 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological progression-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of the ability of the two sequences to predict infusion:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival without neurological signs</measure>
    <time_frame>1 year</time_frame>
    <description>Comparison of the ability of the two sequences to predict infusion:</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lung Carcinoma Metastatic to the Brain</condition>
  <arm_group>
    <arm_group_label>MRI T1 T2 sequences</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>comparison of perfusion sequences T1 T2 in patients with brain metastase cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI T1 T2 sequences</intervention_name>
    <description>MRI</description>
    <arm_group_label>MRI T1 T2 sequences</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major Patients&#xD;
&#xD;
          -  Addressed to MRI for initial assessment of brain metastases&#xD;
&#xD;
          -  At a suspicion of one or more brain metastases in the brain scanner routine screening&#xD;
&#xD;
          -  Followed for lung cancer histologically documented in the Thoracic Oncology Service of&#xD;
             Professor Lafitte (contact: Dr Cortot)&#xD;
&#xD;
          -  To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is&#xD;
             considered&#xD;
&#xD;
          -  Be socially insured-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindication to MRI (pacemaker, implantable pacemaker, metallic foreign&#xD;
             body intraorbital)&#xD;
&#xD;
          -  Patients minors under guardianship / curatorship&#xD;
&#xD;
          -  Patients with impaired judgment skills or unable to receive information&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Patients for which lesions are not compatible with lung metastases&#xD;
&#xD;
          -  Patients with brain metastases or already known and explored MRI&#xD;
&#xD;
          -  Patients for whom treatment by surgical excision of brain metastases is considered&#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>Xavier LECLERC, Professor</last_name>
    <role>Study Director</role>
    <affiliation>CHRU of Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Salengro CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>June 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 3, 2015</last_update_submitted>
  <last_update_submitted_qc>November 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI perfusion</keyword>
  <keyword>therapeutic response</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>brain metastases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT02250755
org study id: 2012_27
secondary id: 2012-A01644-39
nct id: NCT02250755
lead sponsor: 
has dmc: No
This study therefore aims to assess current treatment recommended by scientific societies [
      6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain
      metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg
      [ 14 ] . Sequences infusion different from one center to the other made : some use the
      infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to
      use one or the other of these sequences.

      No examination is added for the purposes of protocol. Indications for MRI and the number and
      timing of MRI checks under this protocol are consistent with what is done in practice . The
      used type of gadolinium and the injected dose will be identical for both sequences infusion .
      The assessment shall not in any case the contrast but the interpretation of the sequence
      itself. Special procedures monitoring implemented embodiment correspond to the two sequences
      instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI
      of the first control , in order to compare their effectiveness
Eligibility criteria:

        -  Major Patients

        -  Addressed MRI for initial assessment of brain metastases

        -  At a suspicion of one or more brain metastases in the brain scanner routine screening

        -  Follow for lung cancer histologically documented

        -  In the Thoracic Oncology Service Professor Lafitte (contact: Dr Cortot)

        -  To whom treatment with chemotherapy or targeted therapy (including anti-angiogenic) is
           considered

        -  Be socially insured

      Main Outcomes measures:

      Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 *
      perfusion during the initial assessment for the diagnosis of maximal tumor response evaluated
      at 1 year
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparing different parameters evaluated in T1 and T2 * perfusion
time frame: 3 years
description: Comparing the area under the ROC curve of different parameters evaluated in T1 and T2 * perfusion during the initial assessment for the diagnosis of maximal tumor
measure: Evaluation tumor response
time frame: 1 year
description: Comparison of the area under the ROC curve of the change in the first control of the various parameters measured in T1 and T2 * infusion, for the diagnosis of maximum tumor response evaluated at 1 year
measure: Radiological progression-free survival
time frame: 1 year
description: Comparison of the ability of the two sequences to predict infusion:
measure: Survival without neurological signs
time frame: 1 year
description: Comparison of the ability of the two sequences to predict infusion:
arm group label: MRI T1 T2 sequences
arm group type: Experimental
description: comparison of perfusion sequences T1 T2 in patients with brain metastase cancer
intervention type: Other
intervention name: MRI T1 T2 sequences
description: MRI
arm group label: MRI T1 T2 sequences
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier LECLERC, Professor
role: Study Director
affiliation: CHRU of Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms