<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/NCT02995889</url>
  </required_header>
  <id_info>
    <org_study_id>308_14</org_study_id>
    <nct_id>NCT02995889</nct_id>
  </id_info>
  <brief_title>FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer</brief_title>
  <official_title>FLT-PET for Early Detection of Relapse in Patients With Irradiated Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <brief_summary>
    <textblock>
      This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in&#xD;
      patients with irradiated lung cancer in comparison with FDG-PET/CT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">February 7, 2020</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</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>Number of patients with local and/or regional relapse</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Lung Cancer, Nonsmall Cell</condition>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>FLT-PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FLT-PET</intervention_name>
    <arm_group_label>FLT-PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history with lung cancer, small cell or non-small cell&#xD;
&#xD;
          -  radiotherapy of lung cancer ended within the last 24 months&#xD;
&#xD;
          -  radiotherapy might be normofractionated or stereotactic&#xD;
&#xD;
          -  current suspicion of relapse&#xD;
&#xD;
          -  written and oral consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  communication difficulties&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Kjær, MD phD MDSci</last_name>
    <role>Study Chair</role>
    <affiliation>Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. Respiratory Medicine, Bispebjerg University Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <results_reference>
    <citation>Christensen TN, Langer SW, Persson G, Larsen KR, Loft A, Amtoft AG, Berthelsen AK, Johannesen HH, Keller SH, Kjaer A, Fischer BM. 18F-FLT PET/CT Adds Value to 18F-FDG PET/CT for Diagnosing Relapse After Definitive Radiotherapy in Patients with Lung Cancer: Results of a Prospective Clinical Trial. J Nucl Med. 2021 May 10;62(5):628-635. doi: 10.2967/jnumed.120.247742. Epub 2020 Oct 9.</citation>
    <PMID>33037090</PMID>
  </results_reference>
  <results_reference>
    <citation>Christensen TN, Langer SW, Persson G, Larsen KR, Amtoft AG, Keller SH, Kjaer A, Fischer BM. Impact of [18F]FDG-PET and [18F]FLT-PET-Parameters in Patients with Suspected Relapse of Irradiated Lung Cancer. Diagnostics (Basel). 2021 Feb 11;11(2):279. doi: 10.3390/diagnostics11020279. Erratum In: Diagnostics (Basel). 2022 Jul 18;12(7):</citation>
    <PMID>33670242</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Tine Nøhr Christensen</investigator_full_name>
    <investigator_title>MD, research fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT02995889
org study id: 308_14
nct id: NCT02995889
lead sponsor: 
This study investigates the feasibility of FLT-PET to improve the diagnosis of relapse in
      patients with irradiated lung cancer in comparison with FDG-PET/CT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients with local and/or regional relapse
time frame: 6 months
arm group label: FLT-PET
arm group type: Experimental
intervention type: Device
intervention name: FLT-PET
arm group label: FLT-PET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Kjær, MD phD MDSci
role: Study Chair
affiliation: Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark
facility: 
facility: 
country: Denmark
citation: Christensen TN, Langer SW, Persson G, Larsen KR, Loft A, Amtoft AG, Berthelsen AK, Johannesen HH, Keller SH, Kjaer A, Fischer BM. 18F-FLT PET/CT Adds Value to 18F-FDG PET/CT for Diagnosing Relapse After Definitive Radiotherapy in Patients with Lung Cancer: Results of a Prospective Clinical Trial. J Nucl Med. 2021 May 10;62(5):628-635. doi: 10.2967/jnumed.120.247742. Epub 2020 Oct 9.
PMID: 33037090
citation: Christensen TN, Langer SW, Persson G, Larsen KR, Amtoft AG, Keller SH, Kjaer A, Fischer BM. Impact of [18F]FDG-PET and [18F]FLT-PET-Parameters in Patients with Suspected Relapse of Irradiated Lung Cancer. Diagnostics (Basel). 2021 Feb 11;11(2):279. doi: 10.3390/diagnostics11020279. Erratum In: Diagnostics (Basel). 2022 Jul 18;12(7):
PMID: 33670242
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Tine Nøhr Christensen
investigator title: MD, research fellow
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Carcinoma, Non-Small-Cell Lung