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/NCT05976620</url>
    </required_header>
    <id_info>
      <org_study_id>SichuanPPH-Breast cancer</org_study_id>
      <nct_id>NCT05976620</nct_id>
    </id_info>
    <brief_title>Clinical Study of 18F-FAPI-RGD in Breast Tumors</brief_title>
    <official_title>Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin avβ3 (FAPI-RGD) in Breast Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sichuan Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sichuan Provincial People's Hospital</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>
        The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT&#xD;
        imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD&#xD;
        PET/CT examination.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast cancer is the most common malignant disease in women worldwide.Early detection,&#xD;
        accurate diagnosis and staging are the keys to effective treatment for breast cancer&#xD;
        patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging&#xD;
        of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for&#xD;
        acute and chronic infections and false-negative uptake for less aggressive histological&#xD;
        subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated&#xD;
        with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could&#xD;
        predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI&#xD;
        PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is&#xD;
        highly expressed in neovascular endothelial cells and tumor cells including breast cancer,&#xD;
        and plays an important role in regulating tumor growth, angiogenesis, local invasion and&#xD;
        metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD&#xD;
        peptides in breast cancer patients has also been reported.&#xD;
  &#xD;
        Several studies have confirmed that the heterodimer is superior to the corresponding monomer&#xD;
        due to the polyvalent effect, thus improving the binding affinity and increasing the number&#xD;
        of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we&#xD;
        synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric&#xD;
        peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been&#xD;
        used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to&#xD;
        use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and&#xD;
        preliminary experiments have confirmed that this examination has a good imaging effect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Correlation between clinical indicators and PET/CT results</measure>
      <time_frame>2 months</time_frame>
      <description>Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers，estrogen assay and 18F-FAPI-RGD PET/CT results</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Breast Tumors</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with diagnosed or highly suspected breast cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 and above&#xD;
  &#xD;
            -  No gender difference&#xD;
  &#xD;
            -  Patients who have been diagnosed with, or are clinically highly suspected of, breast&#xD;
               tumors and have had no other treatment within 3 months&#xD;
  &#xD;
            -  Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed&#xD;
               patients were determined according to the American Joint Committee on Cancer criteria&#xD;
               revised in 2010&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a second primary tumor&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Severe liver or kidney disease&#xD;
  &#xD;
            -  Claustrophobia or other PET/CT scan contraindications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sichuan Provincial People's Hospital</investigator_affiliation>
      <investigator_full_name>Hao Wang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_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/NCT05976620
  org study id: SichuanPPH-Breast cancer
  nct id: NCT05976620
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT
        imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD
        PET/CT examination.
  Breast cancer is the most common malignant disease in women worldwide.Early detection,
        accurate diagnosis and staging are the keys to effective treatment for breast cancer
        patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging
        of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for
        acute and chronic infections and false-negative uptake for less aggressive histological
        subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated
        with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could
        predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI
        PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is
        highly expressed in neovascular endothelial cells and tumor cells including breast cancer,
        and plays an important role in regulating tumor growth, angiogenesis, local invasion and
        metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD
        peptides in breast cancer patients has also been reported.
  
        Several studies have confirmed that the heterodimer is superior to the corresponding monomer
        due to the polyvalent effect, thus improving the binding affinity and increasing the number
        of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we
        synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric
        peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been
        used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to
        use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and
        preliminary experiments have confirmed that this examination has a good imaging effect.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between clinical indicators and PET/CT results
  time frame: 2 months
  description: Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers，estrogen assay and 18F-FAPI-RGD PET/CT results
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Sichuan Provincial People's Hospital
  investigator full name: Hao Wang
  investigator title: Principal Investigator
  mesh term: Breast Neoplasms