<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/NCT02233621</url>
  </required_header>
  <id_info>
    <org_study_id>49RC10_32_01-PHRC2010-02</org_study_id>
    <secondary_id>2011-003734-14</secondary_id>
    <nct_id>NCT02233621</nct_id>
  </id_info>
  <brief_title>Assessment of Performance of [18F]-FES for Endometriosis Diagnosis</brief_title>
  <acronym>ENDOTEP</acronym>
  <official_title>Evaluation Des Performances de la Tomographie Par Emission de Positons Avec la 16α-[18F]Fluoro-17β-estradiol ([18F]-FES) Pour le Diagnostic de l'Endometriose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of&#xD;
      the main problem of endometriosis is the significant delay of diagnosis.This delay has&#xD;
      significant consequences for patients. Currently the definitive diagnosis of endometriosis&#xD;
      and the evaluation of its lesional extension require performing laparoscopy and a&#xD;
      histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose&#xD;
      development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES&#xD;
      (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission&#xD;
      tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this&#xD;
      functional imaging as a diagnostic tool for endometriosis.&#xD;
&#xD;
      The aim of this multicenter, prospective, open study is to assess sensitivity of PET with&#xD;
      [18F] -FES for diagnosing endometriosis compared to the gold standard (histological&#xD;
      confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for&#xD;
      suspected endometriosis and for whom laparoscopy is already scheduled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough enrollement&#xD;
  </why_stopped>
  <start_date>June 2012</start_date>
  <completion_date>April 6, 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 2</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>sensitivity of PET with [18F] -FES for diagnosing endometriosis defined by the ability of this diagnostic exam to give a positive result when endometriosis is present</measure>
    <time_frame>Within 3 months after inclusion when laparoscopy is already scheduled.</time_frame>
    <description>PET with [18F]-FES considered positive if it allows to identify at least one hyperfixation area in a physiologically area not fixing tracer or not corresponding to a physiological removal area tracer.&#xD;
PET results will be correlated with The results of PET with [18F] -FES will be correlated with histology results of at least one of the biopsies performed at laparoscopy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>PET with [18F]-FES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PET with [18F]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>[18F]FES (16α-[18F]Fluoro-17β-estradiol)</intervention_name>
    <description>PET with [18F]FES before coelioscopy</description>
    <arm_group_label>PET with [18F]-FES</arm_group_label>
    <other_name>analog of estrogene</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First planned coelioscopy (therapeutic indication) for suspected endometriosis&#xD;
&#xD;
          -  Patient aged from 18 to 50 years&#xD;
&#xD;
          -  Absence of treatment with GnRH (gonadotropin-releasing hormone) analogue for at least&#xD;
             3 months&#xD;
&#xD;
          -  Patient affiliated to a social security system&#xD;
&#xD;
          -  No hormonal treatment for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of abdominal pelvic surgery for endometriosis&#xD;
&#xD;
          -  Current treatment with GnRH (gonadotropin-releasing hormone) or stopped for less than&#xD;
             3 months&#xD;
&#xD;
          -  hormonal Drug ongoing&#xD;
&#xD;
          -  Patient pregnant, may be or during lactation&#xD;
&#xD;
          -  Patient under guardianship or trusteeship&#xD;
&#xD;
          -  Patient unable to understand the purpose of the study&#xD;
&#xD;
          -  Patient already included in another clinical trial with an experimental molecule.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Descamps, PU-PH</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olivier Couturier, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Céline Lefebvre-Lacoeuille, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nuclear medicin unit, University Hospital of Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</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>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
  </intervention_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/NCT02233621
org study id: 49RC10_32_01-PHRC2010-02
secondary id: 2011-003734-14
nct id: NCT02233621
lead sponsor: 
has dmc: No
Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of
      the main problem of endometriosis is the significant delay of diagnosis.This delay has
      significant consequences for patients. Currently the definitive diagnosis of endometriosis
      and the evaluation of its lesional extension require performing laparoscopy and a
      histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose
      development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES
      (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission
      tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this
      functional imaging as a diagnostic tool for endometriosis.

      The aim of this multicenter, prospective, open study is to assess sensitivity of PET with
      [18F] -FES for diagnosing endometriosis compared to the gold standard (histological
      confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for
      suspected endometriosis and for whom laparoscopy is already scheduled.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: sensitivity of PET with [18F] -FES for diagnosing endometriosis defined by the ability of this diagnostic exam to give a positive result when endometriosis is present
time frame: Within 3 months after inclusion when laparoscopy is already scheduled.
description: PET with [18F]-FES considered positive if it allows to identify at least one hyperfixation area in a physiologically area not fixing tracer or not corresponding to a physiological removal area tracer.
PET results will be correlated with The results of PET with [18F] -FES will be correlated with histology results of at least one of the biopsies performed at laparoscopy.
arm group label: PET with [18F]-FES
arm group type: Experimental
description: PET with [18F]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy.
intervention type: Other
intervention name: [18F]FES (16α-[18F]Fluoro-17β-estradiol)
description: PET with [18F]FES before coelioscopy
arm group label: PET with [18F]-FES
other name: analog of estrogene
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Philippe Descamps, PU-PH
role: Study Chair
affiliation: University Hospital of Angers
last name: Olivier Couturier, PU-PH
role: Principal Investigator
affiliation: University Hospital of Angers
last name: Céline Lefebvre-Lacoeuille, PH
role: Principal Investigator
affiliation: University Hospital of Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate