<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/NCT03288597</url>
  </required_header>
  <id_info>
    <org_study_id>68Ga&amp;FDG PET/CT</org_study_id>
    <nct_id>NCT03288597</nct_id>
  </id_info>
  <brief_title>Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms</brief_title>
  <official_title>A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</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>
      68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment&#xD;
      of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax&#xD;
      of dual imaging associated with pathological findings and prognosis. The study was designed&#xD;
      to confirm thet clinical values of dual imagings for neuroendocrine tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</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>12 Months</target_duration>
  <primary_outcome>
    <measure>The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The correlation between positive rate and SUV of PET/CT and prognosis</measure>
    <time_frame>3 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare SUVmax, tumor/liver ratio as a prognostic marker</measure>
    <time_frame>3 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">146</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <arm_group>
    <arm_group_label>A: advanced and metastatic neuroendocrine tumors</arm_group_label>
    <description>Advanced and metastatic neuroendocrine tumors receive syestematic treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A: advanced and metastatic neuroendocrine carcinomas</arm_group_label>
    <description>Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET</intervention_name>
    <description>At the beginning of the treatment with SSA, after 6 months, 12 months, or chemotherapy, after 3 months or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT</description>
    <arm_group_label>A: advanced and metastatic neuroendocrine tumors</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC</intervention_name>
    <description>At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT</description>
    <arm_group_label>A: advanced and metastatic neuroendocrine carcinomas</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Neuroendocrine neoplasmes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. sign written informed consent form&#xD;
&#xD;
          2. age ≥ 18 years&#xD;
&#xD;
          3. pathologically confirmed neuroendocrine, Ki67&gt;=10%;&#xD;
&#xD;
          4. ECOG 0-1;&#xD;
&#xD;
          5. No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine&#xD;
             carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;&#xD;
&#xD;
          6. Unresectable disease;&#xD;
&#xD;
          7. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded)&#xD;
             (routine CT scan &gt;=20mm, spiral CT scan &gt;=10mm, no prior radiation to measurable&#xD;
             lesions);&#xD;
&#xD;
          8. Predicted survival &gt;=3 months;&#xD;
&#xD;
          9. Negative serum or urine pregnant test within 7 days prior to randomization for&#xD;
             child-bearing age women;&#xD;
&#xD;
         10. Sexually active males or females willing to practice contraception during the study&#xD;
             until 30 days after end of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In the process of antitumor therapy with effective response;&#xD;
&#xD;
          2. Refuse to accept PET/CT;&#xD;
&#xD;
          3. Pregnant or nursing, or sexually active males or females refuse to practice&#xD;
             contraception during the study until 30 days after end of study;&#xD;
&#xD;
          4. Person with no capacity (legally) or inappropriate to continue study treatment for&#xD;
             ethics/medical reasons；&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lin Shen, Professor</last_name>
    <phone>01088196561</phone>
    <email>linshenpku@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shen Lin, Professor</last_name>
      <phone>010-88196561</phone>
      <email>Linshenpku@163.com</email>
    </contact>
    <investigator>
      <last_name>Shen Lin, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 16, 2017</last_update_submitted>
  <last_update_submitted_qc>September 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Shen Lin</investigator_full_name>
    <investigator_title>MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>positive rate</keyword>
  <keyword>SUVmax</keyword>
  <keyword>relationship</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03288597
org study id: 68Ga&FDG PET/CT
nct id: NCT03288597
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment
      of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax
      of dual imaging associated with pathological findings and prognosis. The study was designed
      to confirm thet clinical values of dual imagings for neuroendocrine tumors.
observational model: Cohort
time perspective: Prospective
measure: The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response
time frame: 3 years
measure: The correlation between positive rate and SUV of PET/CT and prognosis
time frame: 3 year
measure: Compare SUVmax, tumor/liver ratio as a prognostic marker
time frame: 3 year
arm group label: A: advanced and metastatic neuroendocrine tumors
description: Advanced and metastatic neuroendocrine tumors receive syestematic treatment
arm group label: A: advanced and metastatic neuroendocrine carcinomas
description: Advanced and metastatic neuroendocrine carcinomas receive syestematic treatment
intervention type: Radiation
intervention name: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET
description: At the beginning of the treatment with SSA, after 6 months, 12 months, or chemotherapy, after 3 months or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT
arm group label: A: advanced and metastatic neuroendocrine tumors
intervention type: Radiation
intervention name: 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC
description: At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT
arm group label: A: advanced and metastatic neuroendocrine carcinomas
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lin Shen, Professor
phone: 01088196561
email: linshenpku@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Shen Lin
investigator title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
mesh term: Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Fluorodeoxyglucose F18
sharing ipd: No