<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/NCT03267459</url>
  </required_header>
  <id_info>
    <org_study_id>ALR_2017_2</org_study_id>
    <nct_id>NCT03267459</nct_id>
  </id_info>
  <brief_title>Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma?</brief_title>
  <acronym>PREDIR</acronym>
  <official_title>Prediction of the Response Using Dynamic Contrast-enhanced Magnetic Resonance Imaging Before Intra-arterial Chemotherapy in Children With Retinoblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all&#xD;
      pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97%&#xD;
      of 5-years survival rate. Conservative treatments are being more and more used, and intra&#xD;
      arterial chemotherapy is one of the adjuvant treatments proposed to the children. The&#xD;
      treatment is efficient in most cases, but a small proportion of children will have an early&#xD;
      progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find&#xD;
      prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for&#xD;
      early identification of children response to intra arterial chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 11, 2018</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>response to chemotherapy</measure>
    <time_frame>18 months</time_frame>
    <description>Persistence of ocular scarring (= favorable outcome)18 months after the end of the treatment by intra-arterial chemotherapy.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Retinoblastoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic contrast-enhanced MRI</intervention_name>
    <description>Dynamic contrast-enhanced perfusion sequences added to MRI examination performed at the beginning of intra arterial chemotherapy.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient with retinoblastoma, undergoing intra arterial chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  grade B to D retinoblastoma&#xD;
&#xD;
          -  prescription of intra arterial chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Augustin Lecler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation OPH A de Rothschild</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurence Salomon, MD PhD</last_name>
    <phone>0148036431</phone>
    <email>lsalomon@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Augustin Lecler, MD</last_name>
    <email>alecler@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fondation A De Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Augustin Lecler</last_name>
      <email>alecler@for.paris</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</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>Retinoblastoma</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/NCT03267459
org study id: ALR_2017_2
nct id: NCT03267459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all
      pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97%
      of 5-years survival rate. Conservative treatments are being more and more used, and intra
      arterial chemotherapy is one of the adjuvant treatments proposed to the children. The
      treatment is efficient in most cases, but a small proportion of children will have an early
      progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find
      prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for
      early identification of children response to intra arterial chemotherapy.
observational model: Case-Only
time perspective: Prospective
measure: response to chemotherapy
time frame: 18 months
description: Persistence of ocular scarring (= favorable outcome)18 months after the end of the treatment by intra-arterial chemotherapy.
intervention type: Device
intervention name: Dynamic contrast-enhanced MRI
description: Dynamic contrast-enhanced perfusion sequences added to MRI examination performed at the beginning of intra arterial chemotherapy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Augustin Lecler, MD
role: Principal Investigator
affiliation: Fondation OPH A de Rothschild
last name: Laurence Salomon, MD PhD
phone: 0148036431
email: lsalomon@for.paris
last name: Augustin Lecler, MD
email: alecler@for.paris
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Retinoblastoma