<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/NCT02971319</url>
  </required_header>
  <id_info>
    <org_study_id>Gliomark</org_study_id>
    <nct_id>NCT02971319</nct_id>
  </id_info>
  <brief_title>Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma</brief_title>
  <official_title>Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Proactina S.A.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ConsulTech GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>pharmtrace</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pharmathen S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Proactina S.A.</source>
  <brief_summary>
    <textblock>
      This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared&#xD;
      to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to&#xD;
      obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an&#xD;
      intra-individual comparison.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 17, 2017</completion_date>
  <primary_completion_date type="Actual">November 17, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical performance of Tc-99m tetrofosmin SPECT</measure>
    <time_frame>assessed once within 3 weeks of inclusion</time_frame>
  </primary_outcome>
  <enrollment type="Actual">32</enrollment>
  <condition>Glioma (Diagnosis)</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tc-99M-Tetrofosmin SPECT</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>F-18 FDG PET</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic&#xD;
             oligodendroglioma, or anaplastic oligoastrocytoma)&#xD;
&#xD;
          2. being in follow-up for at least 3 months after completion of radiation therapy (with&#xD;
             or without concurrent chemotherapy)&#xD;
&#xD;
          3. inconclusive MRI results regarding the differentiation between recurrence and&#xD;
             radiation necrosis&#xD;
&#xD;
          4. willing and able to undergo all study procedures&#xD;
&#xD;
          5. informed consent in writing (dated and signed)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age: less than18 years&#xD;
&#xD;
          2. if female, pregnant or breast feeding (females of child-bearing potential must use&#xD;
             adequate contraception and must have a negative pregnancy test performed within 7 days&#xD;
             prior to inclusion into this study)&#xD;
&#xD;
          3. contraindications for Tc-99m tetrofosmin&#xD;
&#xD;
          4. contraindications for F-18 FDG&#xD;
&#xD;
          5. close affiliation with the investigational site; e.g. first-degree relative of the&#xD;
             investigator&#xD;
&#xD;
          6. participating in another therapeutic clinical trial or has completed study&#xD;
             participation in another therapeutic clinical trial within 5 days of enrolment into&#xD;
             this trial&#xD;
&#xD;
          7. having been previously enrolled in this clinical trial&#xD;
&#xD;
          8. being mentally disabled&#xD;
&#xD;
          9. mental conditions rendering the subject incapable to understand the nature, scope, and&#xD;
             consequences of the trial&#xD;
&#xD;
         10. Being clinically unstable or requiring emergency treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Országos Klinikai Idegtudományi Intézet (OKITI)</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Országos Onkológiai Intézet</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pozitron-Diagnosztika Ltd.</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scanomed Budapest</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uzsoki Utcai Kórház</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Orvos- és Egészségtudományi Centrum</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scanomed Debrecen</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pécsi Tudományegyetem, Általános</name>
      <address>
        <city>Pecs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Hungary</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 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>Glioma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium tc-99m tetrofosmin</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/NCT02971319
org study id: Gliomark
nct id: NCT02971319
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared
      to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to
      obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an
      intra-individual comparison.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Technical performance of Tc-99m tetrofosmin SPECT
time frame: assessed once within 3 weeks of inclusion
intervention type: Device
intervention name: Tc-99M-Tetrofosmin SPECT
intervention type: Device
intervention name: F-18 FDG PET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Hungary
responsible party type: Sponsor
mesh term: Glioma
mesh term: Recurrence
mesh term: Necrosis
mesh term: Technetium tc-99m tetrofosmin