<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/NCT04441606</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-20-ES-0308-CTIL</org_study_id>
    <nct_id>NCT04441606</nct_id>
  </id_info>
  <brief_title>The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies</brief_title>
  <official_title>The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over&#xD;
      18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in&#xD;
      whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other&#xD;
      imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on&#xD;
      malignancies known to show variable avidity to FDG and at times, no uptake at all. Also&#xD;
      patients unable to optimally comply with the required preparation for FDG imaging, such as&#xD;
      diabetic patients who struggle in achieving glycemic control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Actual">June 17, 2020</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>Patients who preformed 68Ga-FAPI-04 PSMA.</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the avidity of various cancers to 68Ga-FAPI-04.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.</measure>
    <time_frame>1 year</time_frame>
    <description>To compare the detectability of FAPI-04 and FDG for malignant lesions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Different Types of Cancer</condition>
  <arm_group>
    <arm_group_label>Different types of cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:&#xD;
Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.&#xD;
Better delineation of tumor extent prior to therapy&#xD;
Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).&#xD;
Patients unable to optimally comply with the required preparation for FDG imaging.&#xD;
The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>68Ga-FAPI-04 PET/CT</intervention_name>
    <description>Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days.&#xD;
Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists.&#xD;
Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression.</description>
    <arm_group_label>Different types of cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The study population will include up to 50 patients with disease in whom a diagnostic&#xD;
        challenge is met, including but not limited to:&#xD;
&#xD;
          1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.&#xD;
&#xD;
          2. Better delineation of tumor extent prior to therapy&#xD;
&#xD;
          3. Malignancies known to show variable avidity to FDG and at times, no uptake at all&#xD;
             (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring&#xD;
             carcinoma).&#xD;
&#xD;
          4. Patients unable to optimally comply with the required preparation for FDG imaging.&#xD;
&#xD;
               -  The study population will include only patients treated in Tel-Aviv Sourasky&#xD;
                  Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of&#xD;
                  whom are part of the hospital staff.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Patients who are reluctant to undergo both FDG and FAPI PET scans.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>IRA DANA</last_name>
    <phone>+97236974373</phone>
    <email>irako@tlvmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>YANA ABRAMOV</last_name>
    <phone>+97236974373</phone>
    <email>irako@tlvmc.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tel Aviv Sourasky medial center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>IRA DANA</last_name>
      <phone>+97236974373</phone>
      <email>irako@tlvmc.gov.il</email>
    </contact>
    <contact_backup>
      <last_name>YANA ABRAMOV</last_name>
      <phone>+97236974373</phone>
      <email>irako@tlvmc.gov.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</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>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04441606
org study id: TASMC-20-ES-0308-CTIL
nct id: NCT04441606
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over
      18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in
      whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other
      imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on
      malignancies known to show variable avidity to FDG and at times, no uptake at all. Also
      patients unable to optimally comply with the required preparation for FDG imaging, such as
      diabetic patients who struggle in achieving glycemic control.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Patients who preformed 68Ga-FAPI-04 PSMA.
time frame: 1 year
description: To evaluate the avidity of various cancers to 68Ga-FAPI-04.
measure: Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.
time frame: 1 year
description: To compare the detectability of FAPI-04 and FDG for malignant lesions.
measure: Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.
time frame: 1 year
description: To evaluate the potential impact of 68Ga-FAPI-04 PET/CT and/or PET/MRI on patient management.
arm group label: Different types of cancer
arm group type: Experimental
description: The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:
Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
Better delineation of tumor extent prior to therapy
Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
Patients unable to optimally comply with the required preparation for FDG imaging.
The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.
intervention type: Radiation
intervention name: 68Ga-FAPI-04 PET/CT
description: Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days.
Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists.
Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression.
arm group label: Different types of cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: IRA DANA
phone: +97236974373
email: irako@tlvmc.gov.il
last name: YANA ABRAMOV
phone: +97236974373
email: irako@tlvmc.gov.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Undecided