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/NCT05982626</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023-545</org_study_id>
      <nct_id>NCT05982626</nct_id>
    </id_info>
    <brief_title>Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer</brief_title>
    <official_title>Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huashan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huashan Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of&#xD;
        patients with Her2-positive metastatic breast cancer after injection of&#xD;
        [131I]/[68Ga]SGMIB-5F7.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">February 14, 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>Dosimetry</measure>
      <time_frame>about 24hours from time of injection</time_frame>
      <description>To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-5F7, assessed by PET/SPECT imaging.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety Assessment</measure>
      <time_frame>From administration of [131I]SGMIB-5F7 until 1 week after injection</time_frame>
      <description>Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>HER2-positive Breast Cancer</condition>
    <arm_group>
      <arm_group_label>68Ga/131I-SGMIB-5F7</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>68Ga/131I-SGMIB-5F7, single dose</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>68Ga/131I-SGMIB-5F7</intervention_name>
      <description>68Ga-SGMIB-5F7: PET imaging; 131I-SGMIB-5F7: SPECT imaging.</description>
      <arm_group_label>68Ga/131I-SGMIB-5F7</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Breast cancer patients.&#xD;
  &#xD;
                 1. Women aged between 18 and 75 years old.&#xD;
  &#xD;
                 2. Patients with breast cancer confirmed by histological examination or imaging.&#xD;
  &#xD;
                 3. HER2 positive diagnosis confirmed by puncture by immunohistochemistry or&#xD;
                    fluorescence in situ hybridization (HER2 positive is defined as&#xD;
                    immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of&#xD;
                    2+/positive in situ hybridization result (IHC 2+/ISH+)).&#xD;
  &#xD;
                 4. Renal function: serum creatinine less than or equal to the upper limit of the&#xD;
                    normal range; electrocardiogram: no significant abnormalities.&#xD;
  &#xD;
                 5. Patients of childbearing age can cooperate with contraception.&#xD;
  &#xD;
                 6. Willing and able to cooperate with all items of this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects meeting any of the following criteria will be excluded from the study:&#xD;
  &#xD;
                 1. Severe hepatic or renal insufficiency;&#xD;
  &#xD;
                 2. Participation in another study protocol or clinical care within the past year&#xD;
                    that has resulted in radiation exposure exceeding an effective dose of 50 mSv in&#xD;
                    addition to the radiation exposure expected from participation in this clinical&#xD;
                    study.&#xD;
  &#xD;
                 3. Participation in this study is considered unsuitable by other investigators.&#xD;
  &#xD;
                 4. Pregnant women and other groups unsuitable to receive radiation.&#xD;
  &#xD;
                 5. Alcohol allergy, etc.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fang Xie, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huashan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yihui Guan, MD</last_name>
      <phone>13764308300</phone>
      <phone_ext>+86</phone_ext>
      <email>guanyihui@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Huashan Hospital</name>
        <address>
          <city>Shanghai</city>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Huashan Hospital</investigator_affiliation>
      <investigator_full_name>YiHui Guan</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Her2-positive</keyword>
    <keyword>Metastatic breast cancer</keyword>
    <keyword>Positron-Emission Tomography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast 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>
  
  
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/NCT05982626
  org study id: KY2023-545
  nct id: NCT05982626
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of
        patients with Her2-positive metastatic breast cancer after injection of
        [131I]/[68Ga]SGMIB-5F7.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Dosimetry
  time frame: about 24hours from time of injection
  description: To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-5F7, assessed by PET/SPECT imaging.
  measure: Safety Assessment
  time frame: From administration of [131I]SGMIB-5F7 until 1 week after injection
  description: Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0
  arm group label: 68Ga/131I-SGMIB-5F7
  arm group type: Experimental
  description: 68Ga/131I-SGMIB-5F7, single dose
  intervention type: Radiation
  intervention name: 68Ga/131I-SGMIB-5F7
  description: 68Ga-SGMIB-5F7: PET imaging; 131I-SGMIB-5F7: SPECT imaging.
  arm group label: 68Ga/131I-SGMIB-5F7
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Fang Xie, PhD
  role: Principal Investigator
  affiliation: Huashan Hospital
  last name: Yihui Guan, MD
  phone: 13764308300
  phone ext: +86
  email: guanyihui@hotmail.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Huashan Hospital
  investigator full name: YiHui Guan
  investigator title: Professor
  mesh term: Breast Neoplasms
  sharing ipd: Undecided