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/NCT05976607</url>
    </required_header>
    <id_info>
      <org_study_id>SichuanPPH- renal tumor</org_study_id>
      <nct_id>NCT05976607</nct_id>
    </id_info>
    <brief_title>Clinical Study of 18F -FAPI-RGD in Renal Tumor</brief_title>
    <official_title>Linical Study of 18F Labeled Probe Targeting Fibroblast Activating Protein and Integrin avβ3 (FAPI-RGD) in Renal 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 Renal Tumor. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT&#xD;
        examination.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Early detection, accurate diagnosis and staging are the keys to effective treatment of kidney&#xD;
        cancer patients.Pathological diagnosis is still the gold standard, but renal perforation is&#xD;
        invasive examination, there are certain complications, the most common is bleeding and&#xD;
        hematoma, rare renal arteriovenous fistula formation and infection.A non-invasive test with&#xD;
        high accuracy is expected.68Ga-FAPI-04 has been reported to be superior to 18F-FDG in the&#xD;
        study of bone metastases in RCC patients, and in addition to detecting more metastases than&#xD;
        18F-FDGPET/CT, uptake is 3-4 times higher than 18F-FDG.There are also many literatures&#xD;
        reporting that APIPET/CT may be better than 18F-FDGPET/CT in the detection of various&#xD;
        malignant tumors, and FAPI targeted imaging is a promising way in the diagnosis and treatment&#xD;
        of papillary renal cell carcinoma.&#xD;
  &#xD;
        18F-FPPRGD2PET/CT may be a useful tool for monitoring early response to anti-angiogenic&#xD;
        therapy in patients with mRCC.18F-FPRGD2PET/CT reliably estimated the expression of integrin&#xD;
        αvβ3 in renal tumors, and in clear cell RCC(ccRCC) groups, 18F-FPRGD2PET signal correlated&#xD;
        with the expression of integrin αvβ3 in tumor cells.In the papillary RCC(pRCC) group, the&#xD;
        signal was correlated with the expression of αvβ3.The expression of integrin αvβ3 in ccRCC&#xD;
        cells was significantly higher than that in pRCC cells.These findings are consistent with&#xD;
        results obtained with other RGD-based tracers in various cancers.The expression level of&#xD;
        integrin αvβ3 in tumor cells is associated with invasiveness and metastasis potential, and&#xD;
        quantifying it with PET may contribute to the study of integrin αvβ3 as a prognostic factor.&#xD;
  &#xD;
        Heterodimer peptide FAPI-RGD was synthesized 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 of patients with various tumors.So, we plan to use&#xD;
        18F-FAPI-RGD PET/CT imaging is used in the diagnosis and treatment of renal 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 Clinical immunohistochemical indexes, ultrasound, enhanced CT, MRI, laboratory examination indexes and 18F-FAPI-RGD PET/CT results</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Renal Tumor</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with diagnosed or highly suspected Renal Tumor&#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, renal&#xD;
               tumors and have had no other treatment within 3 months&#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>Kidney 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/NCT05976607
  org study id: SichuanPPH- renal tumor
  nct id: NCT05976607
  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 Renal Tumor. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT
        examination.
  Early detection, accurate diagnosis and staging are the keys to effective treatment of kidney
        cancer patients.Pathological diagnosis is still the gold standard, but renal perforation is
        invasive examination, there are certain complications, the most common is bleeding and
        hematoma, rare renal arteriovenous fistula formation and infection.A non-invasive test with
        high accuracy is expected.68Ga-FAPI-04 has been reported to be superior to 18F-FDG in the
        study of bone metastases in RCC patients, and in addition to detecting more metastases than
        18F-FDGPET/CT, uptake is 3-4 times higher than 18F-FDG.There are also many literatures
        reporting that APIPET/CT may be better than 18F-FDGPET/CT in the detection of various
        malignant tumors, and FAPI targeted imaging is a promising way in the diagnosis and treatment
        of papillary renal cell carcinoma.
  
        18F-FPPRGD2PET/CT may be a useful tool for monitoring early response to anti-angiogenic
        therapy in patients with mRCC.18F-FPRGD2PET/CT reliably estimated the expression of integrin
        αvβ3 in renal tumors, and in clear cell RCC(ccRCC) groups, 18F-FPRGD2PET signal correlated
        with the expression of integrin αvβ3 in tumor cells.In the papillary RCC(pRCC) group, the
        signal was correlated with the expression of αvβ3.The expression of integrin αvβ3 in ccRCC
        cells was significantly higher than that in pRCC cells.These findings are consistent with
        results obtained with other RGD-based tracers in various cancers.The expression level of
        integrin αvβ3 in tumor cells is associated with invasiveness and metastasis potential, and
        quantifying it with PET may contribute to the study of integrin αvβ3 as a prognostic factor.
  
        Heterodimer peptide FAPI-RGD was synthesized 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 of patients with various tumors.So, we plan to use
        18F-FAPI-RGD PET/CT imaging is used in the diagnosis and treatment of renal 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 Clinical immunohistochemical indexes, ultrasound, enhanced CT, MRI, laboratory examination indexes 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: Kidney Neoplasms