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/NCT05987098</url>
    </required_header>
    <id_info>
      <org_study_id>PekingUMCH-BBPA PET/CT</org_study_id>
      <nct_id>NCT05987098</nct_id>
    </id_info>
    <brief_title>BBPA PET/CT in Patients With Malignant Tumors</brief_title>
    <official_title>Safety and Clinical Value of 18Fluorine-labeled BBPA PET/CT in Patients With Malignant Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Peking University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University Cancer Hospital &amp; Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking Union Medical College 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>
        This study is an open-labeled phase II diagnostic clinical trial to explore the safety and&#xD;
        clinical value of BBPA-PET/CT in suspected malignant tumor patients. The investigation&#xD;
        regarding the clinical value of BBPA concerning the metabolic characteristics of BBPA in&#xD;
        suspected malignant tumors. Quantitative features will be extracted to analysis the PET&#xD;
        images. For patient who took surgery after multiple examination, histopathology, molecular&#xD;
        pathology and LAT-1 immunohistochemistry will also be obtained.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, we utilized BBPA, a novel boron amino acid, which replaces the carboxyl group&#xD;
        of 4-boronate phenylalanine (BPA) with a boron trifluoride group (-BF3) (-COOH), as a&#xD;
        diagnostic molecule for PET imaging of brain tumors, is also a highly efficient boron carrier&#xD;
        for BNCT. Preclinical studies suggested [18F]BBPA to be a pan-cancer probe that transmembrane&#xD;
        transported through large neutral amino acid transporter type-1 (LAT-1). However more studies&#xD;
        and evidence are warranted to investigate the clinical value of BBPA PET imaging in human.&#xD;
  &#xD;
        This study aim to observe the safety of BBPA, and investigate the diagnostic value of BBPA in&#xD;
        the patient with suspected malignant tumors. Patients who meet the eligibility criteria are&#xD;
        included in clinical trials after fully communicating the condition, explaining the benefits&#xD;
        and risks of clinical trials, clarifying the patient's willingness to include the clinical&#xD;
        trial, and signing informed consent. The cohort number, BBPA administrative dose, imaging&#xD;
        protocols are decided based on the investigators' preliminary data. The diagnosis and post-&#xD;
        examination treatment are based on the recommended guideline, combined with the subject's own&#xD;
        situation for standardized diagnosis and treatment&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 20, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>
      <intervention_model_description>A single dose of BBPA will be intravenously injected and PET examination will carry out 30 minutes later.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>standardized uptake value (SUV) for BBPA</measure>
      <time_frame>1 week</time_frame>
      <description>SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually assessed features will be measured in the evaluation of tumors.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>1 week</time_frame>
      <description>Adverse event within 1 week after BBPA injection will be documented.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Malignant Tumors</condition>
    <arm_group>
      <arm_group_label>Malignant Tumors</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BBPA in suspected malignant tumors. This arm investigates the metabolic characteristics of BBPA in suspected malignant tumor patients who consider for surgical operations. A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later. Surgical operations, if recommended after multiple examination, will be carried out within 1 week after BBPA PET scan.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>BBPA PET examination</intervention_name>
      <description>A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later.</description>
      <arm_group_label>Malignant Tumors</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have suspected diagnosis of brain tumors, based on clinical performance and imaging&#xD;
               results.&#xD;
  &#xD;
            -  Meet the indications for PET examination, show a clear indication and no&#xD;
               contraindications;&#xD;
  &#xD;
            -  Have a performance status of score ≥80 on KPS scale or score 0-1 points on ECOG scale,&#xD;
               a relatively good general situation;&#xD;
  &#xD;
            -  Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart,&#xD;
               lung, liver, kidney and other major organ include), acute or life-threatening status&#xD;
               of infection;&#xD;
  &#xD;
            -  Be ≥ 18 years of age on day of signing informed consent.&#xD;
  &#xD;
            -  Be willing and able to understand the research content and provide written informed&#xD;
               consent/assent for the trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a history of imaging agent allergies;&#xD;
  &#xD;
            -  Does not meet the PET-CT scan sedation requirements, or there are contraindications&#xD;
               for PET-CT examination;&#xD;
  &#xD;
            -  Be pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
               projected duration of the trial;&#xD;
  &#xD;
            -  Unable to adhere strictly to protocol requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Wenbin Ma</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>10005</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenbin Ma, M.D.</last_name>
        <phone>+8613701364566</phone>
        <email>mawb2001@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>malignant tumors</keyword>
    <keyword>BBPA-PET/CT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05987098
  org study id: PekingUMCH-BBPA PET/CT
  nct id: NCT05987098
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is an open-labeled phase II diagnostic clinical trial to explore the safety and
        clinical value of BBPA-PET/CT in suspected malignant tumor patients. The investigation
        regarding the clinical value of BBPA concerning the metabolic characteristics of BBPA in
        suspected malignant tumors. Quantitative features will be extracted to analysis the PET
        images. For patient who took surgery after multiple examination, histopathology, molecular
        pathology and LAT-1 immunohistochemistry will also be obtained.
  In this study, we utilized BBPA, a novel boron amino acid, which replaces the carboxyl group
        of 4-boronate phenylalanine (BPA) with a boron trifluoride group (-BF3) (-COOH), as a
        diagnostic molecule for PET imaging of brain tumors, is also a highly efficient boron carrier
        for BNCT. Preclinical studies suggested [18F]BBPA to be a pan-cancer probe that transmembrane
        transported through large neutral amino acid transporter type-1 (LAT-1). However more studies
        and evidence are warranted to investigate the clinical value of BBPA PET imaging in human.
  
        This study aim to observe the safety of BBPA, and investigate the diagnostic value of BBPA in
        the patient with suspected malignant tumors. Patients who meet the eligibility criteria are
        included in clinical trials after fully communicating the condition, explaining the benefits
        and risks of clinical trials, clarifying the patient's willingness to include the clinical
        trial, and signing informed consent. The cohort number, BBPA administrative dose, imaging
        protocols are decided based on the investigators' preliminary data. The diagnosis and post-
        examination treatment are based on the recommended guideline, combined with the subject's own
        situation for standardized diagnosis and treatment
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: A single dose of BBPA will be intravenously injected and PET examination will carry out 30 minutes later.
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: standardized uptake value (SUV) for BBPA
  time frame: 1 week
  description: SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually assessed features will be measured in the evaluation of tumors.
  measure: Adverse events
  time frame: 1 week
  description: Adverse event within 1 week after BBPA injection will be documented.
  arm group label: Malignant Tumors
  arm group type: Experimental
  description: BBPA in suspected malignant tumors. This arm investigates the metabolic characteristics of BBPA in suspected malignant tumor patients who consider for surgical operations. A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later. Surgical operations, if recommended after multiple examination, will be carried out within 1 week after BBPA PET scan.
  intervention type: Diagnostic Test
  intervention name: BBPA PET examination
  description: A single dose of 0.10 mCi/kg BBPA will be intravenously injected and PET examination will carry out 30 minutes later.
  arm group label: Malignant Tumors
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No