<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/NCT04469244</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI063</org_study_id>
    <nct_id>NCT04469244</nct_id>
  </id_info>
  <brief_title>Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas</brief_title>
  <acronym>RADDOPAG</acronym>
  <official_title>Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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 evaluation of gliomas in imaging represents a real challenge today, at the initial&#xD;
      diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an&#xD;
      urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At&#xD;
      present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis&#xD;
      with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging,&#xD;
      through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it&#xD;
      remains time-consuming and is not always available. At the same time, positron emission&#xD;
      tomography (PET) with amino acids is an interesting alternative for these brain tumours.&#xD;
      Amino acid PET has the advantage of being more specific than the abnormalities detected in&#xD;
      MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike&#xD;
      Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the&#xD;
      non-invasive staging of gliomas at initial diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 3, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluating the performance of radiomics use in gliomas at initial diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Assessing the performance of radiomics use in the search for glioma recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluating the performance of the use of radiomics in the follow-up of glioma disease treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data</measure>
    <time_frame>6 months</time_frame>
    <description>Optimization of dynamic analysis for the interpretation of the PET/CT examination at 18F-FDOPA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data</measure>
    <time_frame>1 years</time_frame>
    <description>Comparison of diagnostic performance of radiomics, static and dynamic parameters.</description>
  </secondary_outcome>
  <enrollment type="Actual">1000</enrollment>
  <condition>Study on the Use of Radiomics in Gliomas of Initial Disgnosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        common population that underwent a PET/CT scan at 18F-FDOPA for its glioma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the&#xD;
             nuclear medicine department of the CHRU de Brabois for which the raw data are&#xD;
             available;&#xD;
&#xD;
          -  Person who received full information on the organization of the research and did not&#xD;
             object to the use of these data;&#xD;
&#xD;
          -  Patients affiliated to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Person who received full information on the organization of the research and who&#xD;
             objected to the use of the data&#xD;
&#xD;
          -  Adult person subject to a legal protection measure (guardianship, curatorship,&#xD;
             safeguard of justice).&#xD;
&#xD;
          -  A person of full age who is unable to give consent and who is not subject to a legal&#xD;
             protection measure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHRU of Nancy</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>Antoine VERGER</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>18F-FDOPA</keyword>
  <keyword>Glioma</keyword>
  <keyword>Radiomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</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/NCT04469244
org study id: 2020PI063
nct id: NCT04469244
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The evaluation of gliomas in imaging represents a real challenge today, at the initial
      diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an
      urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At
      present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis
      with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging,
      through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it
      remains time-consuming and is not always available. At the same time, positron emission
      tomography (PET) with amino acids is an interesting alternative for these brain tumours.
      Amino acid PET has the advantage of being more specific than the abnormalities detected in
      MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike
      Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the
      non-invasive staging of gliomas at initial diagnosis.
observational model: Case-Only
time perspective: Retrospective
measure: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the molecular characteristics of gliomas at initial diagnosis.
time frame: 1 year
description: Evaluating the performance of radiomics use in gliomas at initial diagnosis
measure: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict glioma recurrence
time frame: 1 year
description: Assessing the performance of radiomics use in the search for glioma recurrence
measure: Diagnostic performance (sensitivity, specificity, accuracy) of parameters extracted from radiomic analysis to predict the response to glioma treatments.
time frame: 1 year
description: Evaluating the performance of the use of radiomics in the follow-up of glioma disease treatments
measure: Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
time frame: 6 months
description: Optimization of dynamic analysis for the interpretation of the PET/CT examination at 18F-FDOPA
measure: Comparison of dynamic parameters (time to peak, slope, area under curve) obtained with different reconstruction parameters versus dynamic parameters obtained on digital phantom from literature data
time frame: 1 years
description: Comparison of diagnostic performance of radiomics, static and dynamic parameters.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: Antoine VERGER
investigator title: MD, PhD
mesh term: Glioma