xml: <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/NCT05999227</url>
    </required_header>
    <id_info>
      <org_study_id>XLan-0379</org_study_id>
      <nct_id>NCT05999227</nct_id>
    </id_info>
    <brief_title>68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy</brief_title>
    <official_title>68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy: A Single-center Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET&#xD;
        imaging in early response evaluation of rectal cancer patients treated with immunotherapy.&#xD;
        Patients with histopathologically confirmed diagnosis of rectal cancer will be recruited and&#xD;
        undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after short-course&#xD;
        radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging&#xD;
        intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early response&#xD;
        evaluation will be compared with the general imaging agent 18F-FDG. The general information,&#xD;
        clinical data, mpMRI data, 68Ga-FAPI-04 and 18F-FDG PET imaging results and other imaging&#xD;
        data of the patients will be collected. The histopathology of the biopsy or surgical specimen&#xD;
        after 2 cycles of therapy and follow-up data will be taken as evaluation references. This&#xD;
        study plans to set the sample size as 20 cases&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The response patterns of immune checkpoint inhibitors (ICIs) in solid tumors are diverse and&#xD;
        complicated. Pseudoprogression, progression and even hyperprogression can occur. The main&#xD;
        mechanism of pseudoprogression is the infiltration of immune cells into the tumor lesion,&#xD;
        causing blurred tumor margins and even an increase in the volume of the entire tumor lesion&#xD;
        (secondary delayed response). For pseudoprogression, irRC, irRECIST, iRECIST and other&#xD;
        immune-related solid tumor efficacy evaluation criteria based on anatomical images are not&#xD;
        enough to confirm, and the inflammation caused by T cell infiltration also shows strong&#xD;
        uptake of 18F-FDG. The existing criteria for the response evaluation in solid tumors cannot&#xD;
        early identify progression or pseudoprogression.&#xD;
  &#xD;
        Fibroblast activation protein (FAP) is highly specifically expressed on the membrane surface&#xD;
        of carcinoma-associated fibroblast (CAF). FAP-positive CAFs exist in a variety of solid&#xD;
        tumors including rectal cancer and are mainly involved in the formation of tumor stroma.&#xD;
        However, FAP is rarely expressed in normal tissues. Therefore, 68Ga-FAPI-04 PET, a&#xD;
        FAP-targeted imaging modality, can be used to differentiate tumors and normal tissues and has&#xD;
        been widely used in clinical studies. Its sensitivity and specificity outperformed 18F-FDG&#xD;
        PET. Studies have shown that tumors with high FAP expression are associated with poor&#xD;
        response immunotherapy. Although FAP-targeted imaging has been widely used in predicting the&#xD;
        response to immune checkpoint inhibitors, it has rarely been reported in rectal cancer.&#xD;
  &#xD;
        This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET&#xD;
        imaging in the early response evaluation of rectal cancer patients treated with&#xD;
        immunotherapy. Patients with histopathologically confirmed diagnosis of rectal cancer will be&#xD;
        recruited and undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after&#xD;
        short-course radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The&#xD;
        two imaging intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early&#xD;
        response evaluation will be compared with the general imaging agent 18F-FDG.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>68Ga-FAPI-04 PET analysis</measure>
      <time_frame>Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)</time_frame>
      <description>PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>18F-FDG PET analysis</measure>
      <time_frame>Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)</time_frame>
      <description>PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Rectal Cancer</condition>
    <arm_group>
      <arm_group_label>Immunotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with rectal cancer will receive short-course radiotherapy and neoadjuvant chemotherapy plus immunotherapy.&#xD;
  68Ga-FAPI-04 and 18F-FDG PET will be performed at baseline and after short-course radiotherapy and 2 cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>68Ga-FAPI-04</intervention_name>
      <description>A fibroblast activation protein (FAP) -targeted PET imaging agent</description>
      <arm_group_label>Immunotherapy</arm_group_label>
      <other_name>68Ga-FAPI</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>18F-FDG</intervention_name>
      <description>A general glucose metabolism imaging agent</description>
      <arm_group_label>Immunotherapy</arm_group_label>
      <other_name>18F-fluorodeoxyglucose</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed T3-4N0M0 or T1-4N+M0 (according to the 8th edition of the&#xD;
               International Union Against Cancer TNM staging system) rectal adenocarcinoma and&#xD;
               treatment naïve;&#xD;
  &#xD;
            -  No severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities&#xD;
               or immunodeficiency diseases;&#xD;
  &#xD;
            -  An Eastern Cooperative Oncology Group Performance Status of 0-1;&#xD;
  &#xD;
            -  Patients who agree to undergo 68Ga-FAPI-04 and 18F-FDG PET imaging.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any experiences of anti-programmed death ligand 1 (PD-L1) or anti-PD-1 antibody&#xD;
               treatment;&#xD;
  &#xD;
            -  A history of pelvic radiation;&#xD;
  &#xD;
            -  The presence of autoimmune disease;&#xD;
  &#xD;
            -  Hypersensitive to any monoclonal antibodies;&#xD;
  &#xD;
            -  History of interstitial lung disease;&#xD;
  &#xD;
            -  Active and uncontrolled infection.&#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>Xiaoli Lan</last_name>
      <role>Study Director</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaoli Lan</last_name>
      <phone>0086-027-83692633</phone>
      <email>lxl730724@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>China, Hubei Province</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaoli Lan, PhD</last_name>
        <phone>+86-027-83692633</phone>
        <email>lxl730724@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorodeoxyglucose F18</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999227
  org study id: XLan-0379
  nct id: NCT05999227
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET
        imaging in early response evaluation of rectal cancer patients treated with immunotherapy.
        Patients with histopathologically confirmed diagnosis of rectal cancer will be recruited and
        undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after short-course
        radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging
        intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early response
        evaluation will be compared with the general imaging agent 18F-FDG. The general information,
        clinical data, mpMRI data, 68Ga-FAPI-04 and 18F-FDG PET imaging results and other imaging
        data of the patients will be collected. The histopathology of the biopsy or surgical specimen
        after 2 cycles of therapy and follow-up data will be taken as evaluation references. This
        study plans to set the sample size as 20 cases
  The response patterns of immune checkpoint inhibitors (ICIs) in solid tumors are diverse and
        complicated. Pseudoprogression, progression and even hyperprogression can occur. The main
        mechanism of pseudoprogression is the infiltration of immune cells into the tumor lesion,
        causing blurred tumor margins and even an increase in the volume of the entire tumor lesion
        (secondary delayed response). For pseudoprogression, irRC, irRECIST, iRECIST and other
        immune-related solid tumor efficacy evaluation criteria based on anatomical images are not
        enough to confirm, and the inflammation caused by T cell infiltration also shows strong
        uptake of 18F-FDG. The existing criteria for the response evaluation in solid tumors cannot
        early identify progression or pseudoprogression.
  
        Fibroblast activation protein (FAP) is highly specifically expressed on the membrane surface
        of carcinoma-associated fibroblast (CAF). FAP-positive CAFs exist in a variety of solid
        tumors including rectal cancer and are mainly involved in the formation of tumor stroma.
        However, FAP is rarely expressed in normal tissues. Therefore, 68Ga-FAPI-04 PET, a
        FAP-targeted imaging modality, can be used to differentiate tumors and normal tissues and has
        been widely used in clinical studies. Its sensitivity and specificity outperformed 18F-FDG
        PET. Studies have shown that tumors with high FAP expression are associated with poor
        response immunotherapy. Although FAP-targeted imaging has been widely used in predicting the
        response to immune checkpoint inhibitors, it has rarely been reported in rectal cancer.
  
        This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET
        imaging in the early response evaluation of rectal cancer patients treated with
        immunotherapy. Patients with histopathologically confirmed diagnosis of rectal cancer will be
        recruited and undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after
        short-course radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The
        two imaging intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early
        response evaluation will be compared with the general imaging agent 18F-FDG.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: 68Ga-FAPI-04 PET analysis
  time frame: Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
  description: PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.
  measure: 18F-FDG PET analysis
  time frame: Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
  description: PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.
  arm group label: Immunotherapy
  arm group type: Experimental
  description: Patients with rectal cancer will receive short-course radiotherapy and neoadjuvant chemotherapy plus immunotherapy.
  68Ga-FAPI-04 and 18F-FDG PET will be performed at baseline and after short-course radiotherapy and 2 cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart.
  intervention type: Drug
  intervention name: 68Ga-FAPI-04
  description: A fibroblast activation protein (FAP) -targeted PET imaging agent
  arm group label: Immunotherapy
  other name: 68Ga-FAPI
  intervention type: Drug
  intervention name: 18F-FDG
  description: A general glucose metabolism imaging agent
  arm group label: Immunotherapy
  other name: 18F-fluorodeoxyglucose
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaoli Lan
  role: Study Director
  affiliation: Wuhan Union Hospital, China
  last name: Xiaoli Lan
  phone: 0086-027-83692633
  email: lxl730724@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Rectal Neoplasms
  mesh term: Fluorodeoxyglucose F18