<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/NCT02186678</url>
  </required_header>
  <id_info>
    <org_study_id>2013-26</org_study_id>
    <nct_id>NCT02186678</nct_id>
  </id_info>
  <brief_title>Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation</brief_title>
  <acronym>DOTATATE</acronym>
  <official_title>Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation: Monocentric Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and&#xD;
      Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as&#xD;
      dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine&#xD;
      Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography)&#xD;
      imaging using peptide receptors has gained an increasing role in the management of NETs. The&#xD;
      use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of&#xD;
      Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of&#xD;
      SSTRs-expressing tumors, including PGLs.&#xD;
&#xD;
      In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than&#xD;
      other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the&#xD;
      most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and&#xD;
      68Ga-DOTATATE PET-CT have never been compared in this clinical setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2014</start_date>
  <completion_date type="Actual">April 5, 2023</completion_date>
  <primary_completion_date type="Actual">October 5, 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>interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL</measure>
    <time_frame>7 months</time_frame>
    <description>The primary outcome measure is to determine the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL. We will document the number of additional foci detected by 68Ga-DOTATATE PET-CT compared to 18F-FDOPA PET-CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>assesment of 68Ga-DOTATATE PET-CT to anatomical imaging</measure>
    <time_frame>7 months</time_frame>
    <description>The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location</description>
  </secondary_outcome>
  <other_outcome>
    <measure>assesment of 68Ga-DOTATATE PET-CT to anatomical imaging</measure>
    <time_frame>7 months</time_frame>
    <description>The third objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning the genetic status,</description>
  </other_outcome>
  <other_outcome>
    <measure>assesment of 68Ga-DOTATATE PET-CT to anatomical imaging</measure>
    <time_frame>7 months</time_frame>
    <description>The fourth objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning Somatostatin receptor expression</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Paragangliomas</condition>
  <condition>Pheochromocytomas</condition>
  <arm_group>
    <arm_group_label>assesment by 68Ga-DOTATATE PET-CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET-CT</intervention_name>
    <arm_group_label>assesment by 68Ga-DOTATATE PET-CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age ≥ 18&#xD;
&#xD;
          -  PHEO or PGL: initial staging or restaging&#xD;
&#xD;
          -  Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT&#xD;
             scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant or breast-feeding woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David TAIEB, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 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>Pheochromocytoma</mesh_term>
    <mesh_term>Paraganglioma</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/NCT02186678
org study id: 2013-26
nct id: NCT02186678
lead sponsor: 
has dmc: No
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and
      Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as
      dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine
      Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography)
      imaging using peptide receptors has gained an increasing role in the management of NETs. The
      use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of
      Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of
      SSTRs-expressing tumors, including PGLs.

      In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than
      other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the
      most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and
      68Ga-DOTATATE PET-CT have never been compared in this clinical setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: interest of the the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL
time frame: 7 months
description: The primary outcome measure is to determine the contribution of 68Ga-DOTATATE PET-CT in the staging of PHEO/PGL. We will document the number of additional foci detected by 68Ga-DOTATATE PET-CT compared to 18F-FDOPA PET-CT.
measure: assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
time frame: 7 months
description: The secondary objective is to compare , to assess the factors influencing its sensitivity concerning the tumor location
measure: assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
time frame: 7 months
description: The third objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning the genetic status,
measure: assesment of 68Ga-DOTATATE PET-CT to anatomical imaging
time frame: 7 months
description: The fourth objective is to compare 68Ga-DOTATATE PET-CT to anatomical imaging, to assess the factors influencing its sensitivity concerning Somatostatin receptor expression
arm group label: assesment by 68Ga-DOTATATE PET-CT
arm group type: Experimental
intervention type: Other
intervention name: PET-CT
arm group label: assesment by 68Ga-DOTATATE PET-CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: David TAIEB, MD
role: Principal Investigator
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Pheochromocytoma
mesh term: Paraganglioma