<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/NCT03790423</url>
  </required_header>
  <id_info>
    <org_study_id>AK2018_1</org_study_id>
    <secondary_id>2015-005583-42</secondary_id>
    <nct_id>NCT03790423</nct_id>
  </id_info>
  <brief_title>18F-ASIS PET/CT Imaging of Tissue Factor Expression In Patients With Primary and Metastastic Cancer</brief_title>
  <official_title>Phase I: PET Imaging of Tissue Factor (TF) Expression in Patients With Primary and Metastastic Cancer Using 18F-ASIS.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</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 primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging&#xD;
      of tissue factor (TF) expression. The tracer has the potential of identifying tumors with&#xD;
      high levels of TF expression, which is expected to correlate with tumor aggression and&#xD;
      prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic&#xD;
      agent for identifying patients eligible for TF directed therapies.&#xD;
&#xD;
      This is a first-in-man study to test the radio tracer in cancer patients. Safety,&#xD;
      biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and&#xD;
      4 hours post-injection).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging&#xD;
      of tissue factor (TF) expression. The tracer has the potential of identifying tumors with&#xD;
      high levels of TF expression, which is expected to correlate with tumor aggression and&#xD;
      prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic&#xD;
      agent for identifying patients eligible for TF directed therapies.&#xD;
&#xD;
      This is a first-in-man study to test the radio tracer in cancer patients. Safety,&#xD;
      biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and&#xD;
      4 hours post-injection).&#xD;
&#xD;
      The primary end points are safety, biodistribution and dosimetry of 18F-ASIS. In addition,&#xD;
      the quantitative uptake of 18F-ASIS will be compared to the expression of TF measured&#xD;
      directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and&#xD;
      evaluated in accordance with the principles of Good Clinical Practice (GCP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">November 18, 2019</completion_date>
  <primary_completion_date type="Actual">November 18, 2019</primary_completion_date>
  <phase>Phase 1</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>1.Biodistribution of the radiotracer 18F-ASIS estimated by PET</measure>
    <time_frame>4 hours</time_frame>
    <description>The biodistribution of the 18F-ASIS radiotracer estimated from the standardized uptake values (SUV) of the major organs obtained from the patient's repeated PET imaging with the radiotracer 18F-ASIS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2.Dosimetry of the radiotracer 18F-ASIS estimated by PET</measure>
    <time_frame>4 hours</time_frame>
    <description>Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 18F-ASIS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>48 hours</time_frame>
    <description>The safety of 18F-ASIS PET as measured by the number of participants with adverse events within 48 hours following the 18F-ASIS PET assessed by CTCAE v5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue</measure>
    <time_frame>4 hours</time_frame>
    <description>The patients will be PET scanned 1 hour, 2 hours and 4 hours post-injection of the radiotracer 18F-ASIS. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Lung Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Cervix Cancer</condition>
  <arm_group>
    <arm_group_label>18F-ASIS PET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Injection of 18F-ASIS</intervention_name>
    <description>Each patient will receive one injection of 18F-ASIS (approximately 200 Mbq)</description>
    <arm_group_label>18F-ASIS PET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PET/CT scan</intervention_name>
    <description>Following one injection of 18F-ASIS the patients will be PET/CT scanned at 1 hour, 2 hours and 4 hours post-injection</description>
    <arm_group_label>18F-ASIS PET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with breast, lung, pancreatic, cervix or ovarian cancer&#xD;
&#xD;
          -  Capable of understanding the patient information in Danish and giving full informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breast-feeding&#xD;
&#xD;
          -  Weight above 140 kg&#xD;
&#xD;
          -  History of allergic reaction attributable to compounds of similar chemical or biologic&#xD;
             composition to 18F-ASIS&#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>Mathias D Loft, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Mathias Dyrberg Loft</investigator_full_name>
    <investigator_title>Principal Investigator, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</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/NCT03790423
org study id: AK2018_1
secondary id: 2015-005583-42
nct id: NCT03790423
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging
      of tissue factor (TF) expression. The tracer has the potential of identifying tumors with
      high levels of TF expression, which is expected to correlate with tumor aggression and
      prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic
      agent for identifying patients eligible for TF directed therapies.

      This is a first-in-man study to test the radio tracer in cancer patients. Safety,
      biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and
      4 hours post-injection).
The primary objective of the trial is to test the new radio tracer 18F-ASIS for PET imaging
      of tissue factor (TF) expression. The tracer has the potential of identifying tumors with
      high levels of TF expression, which is expected to correlate with tumor aggression and
      prognosis. Furthermore, the tracer can potentially be used as companion imaging diagnostic
      agent for identifying patients eligible for TF directed therapies.

      This is a first-in-man study to test the radio tracer in cancer patients. Safety,
      biodistribution and dosimetry will be evaluated by repeated PET imaging (1 hour, 2 hours and
      4 hours post-injection).

      The primary end points are safety, biodistribution and dosimetry of 18F-ASIS. In addition,
      the quantitative uptake of 18F-ASIS will be compared to the expression of TF measured
      directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and
      evaluated in accordance with the principles of Good Clinical Practice (GCP).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 1.Biodistribution of the radiotracer 18F-ASIS estimated by PET
time frame: 4 hours
description: The biodistribution of the 18F-ASIS radiotracer estimated from the standardized uptake values (SUV) of the major organs obtained from the patient's repeated PET imaging with the radiotracer 18F-ASIS
measure: 2.Dosimetry of the radiotracer 18F-ASIS estimated by PET
time frame: 4 hours
description: Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 18F-ASIS
measure: 3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 48 hours
description: The safety of 18F-ASIS PET as measured by the number of participants with adverse events within 48 hours following the 18F-ASIS PET assessed by CTCAE v5.0
measure: 1.Quantitative uptake of the radiotracer 18F-ASIS in tumor tissue
time frame: 4 hours
description: The patients will be PET scanned 1 hour, 2 hours and 4 hours post-injection of the radiotracer 18F-ASIS. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).
arm group label: 18F-ASIS PET
arm group type: Experimental
description: One injection of 18F-ASIS (app. 200 MBq) followed by 3 PET/CT scans 1 hour, 2 hours and 4hours post-injection
intervention type: Drug
intervention name: Injection of 18F-ASIS
description: Each patient will receive one injection of 18F-ASIS (approximately 200 Mbq)
arm group label: 18F-ASIS PET
intervention type: Other
intervention name: PET/CT scan
description: Following one injection of 18F-ASIS the patients will be PET/CT scanned at 1 hour, 2 hours and 4 hours post-injection
arm group label: 18F-ASIS PET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathias D Loft, MD
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Mathias Dyrberg Loft
investigator title: Principal Investigator, MD
mesh term: Uterine Cervical Neoplasms