<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/NCT03830242</url>
  </required_header>
  <id_info>
    <org_study_id>ZDWY.JRWK.001</org_study_id>
    <nct_id>NCT03830242</nct_id>
  </id_info>
  <brief_title>Diagnostic Significance of FDG PET/CT Dynamic Imaging in Detecting Metastatic Lymph Nodes With Papillary Thyroid Cancer.</brief_title>
  <official_title>Diagnostic Significance of Single Center, Open and Prospective Evaluation of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT Dynamic Imaging in Detecting Metastatic Central Lymph Nodes in Patients With Papillary Thyroid Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fifth Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fifth Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this study is to make up for the gap by performing a dynamic scan of&#xD;
      &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT on newly diagnosed patients with papillary thyroid carcinoma.&#xD;
      Pathological and genomic studies are performed. The differences between metastatic central&#xD;
      lymph nodes images and tissues are compared at the same time. &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT&#xD;
      dynamic imaging is explored in metastatic central lymph nodes with papillary thyroid cancer&#xD;
      for the diagnostic value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thyroid cancer is the most common malignant tumor in human endocrine system, accounting for&#xD;
      0.2% ~ 1.0% of malignant tumors .According to the global cancer report released by the world&#xD;
      health organization (WHO) in 2014, 50% of the new cases of thyroid cancer are papillary&#xD;
      thyroid cancer (PTC). In recent years, the incidence of thyroid cancer in China shows an&#xD;
      increasing trend, especially the composition ratio of thyroid micro-papillary carcinoma with&#xD;
      the focal diameter &lt;1 cm increases rapidly.Although PTC has a good prognosis, according to a&#xD;
      Meta analysis , PTC lymph node metastasis rate is as high as 28.0%.The central lymph node is&#xD;
      the most common metastatic site of papillary thyroid carcinoma.In addition, it has been&#xD;
      reported in literature that lymph nodes in the central region are the first stop of thyroid&#xD;
      papillary carcinoma metastasis (i.e., sentinel lymph nodes), and lymph nodes metastatic to&#xD;
      this point are prone to infringe the peripheral esophagus, trachea and recurrent laryngeal&#xD;
      nerve at an early stage.A large number of clinical cases have confirmed that lymph node&#xD;
      metastasis of thyroid cancer significantly increases the local recurrence rate after&#xD;
      surgery.More studies have shown that regional lymph node metastasis increases&#xD;
      mortality.Therefore, the treatment of lymph node metastasis should not be ignored in PTC&#xD;
      patients.However, at present, preoperative imaging has certain limitations in the judgment of&#xD;
      lymph node metastasis in the central region : ultrasound has advantages in the judgment of&#xD;
      lymph node metastasis in the peripheral group, but poor display in the central group.Although&#xD;
      MRI scan of head and neck can be multi-directional and multi-sequence imaging, and the&#xD;
      resolution of soft tissue is high, it is not good at showing calcification.Conventional CT&#xD;
      alone based on lymph node morphology to determine metastasis also has some&#xD;
      limitations;Positron emission tomography (PET) sensitivity was &lt; 40%.Although one study&#xD;
      showed that the probability of non-missed diagnosis of lymph nodes in central PTC region by&#xD;
      thin slice CT scan was 100%, the specificity was low and the study was&#xD;
      retrospective.Therefore, b-ultrasound, MRI, CT, PET and other auxiliary examinations have not&#xD;
      been able to effectively detect all central metastatic lymph nodes before surgery.For&#xD;
      management of cervical lymph nodes ,2015 American Thyroid Association（ATA） guidelines show&#xD;
      that thyroid+therapeutic Ⅵ area lymph node dissection should be undertaken if in central or&#xD;
      lateral lymph nodes are involved.Chinese guidelines recommend that, in order to avoid&#xD;
      operative complications as far as possible (i.e. effective retainment of the parathyroid&#xD;
      gland and recurrent laryngeal nerve), regardless of the size of the primary thyroid lesion,&#xD;
      lymph node dissection in the central area on the same side of the lesion should be performed&#xD;
      at least.However, in 2017, the second edition of National Comprehensive Cancer Network(NCCN)&#xD;
      thyroid tumor guidelines believed that if lymph nodes in the central region were negative,&#xD;
      preventive central region lymph node dissection was not recommended.Above all，there is so&#xD;
      much controversy over lymph node dissection in the central region. Therefore，it is of great&#xD;
      significance to effectively evaluate the preoperative lymph nodes station in the central&#xD;
      region of thyroid papillary carcinoma.&#xD;
&#xD;
      Early dynamic imaging examination of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT can be defined as a imaging&#xD;
      method to detect the status of radioactive tracer (&lt;Sup&gt;18&lt;Sup&gt;F-FDG) which travels with the&#xD;
      blood flow and is continuously absorbed and excreted by organs (or diseased) tissues after&#xD;
      being introduced into the body in the early stage.This development reflects the change of&#xD;
      &lt;Sup&gt;18&lt;Sup&gt;F-FDG activity with time in the early stage of entering the body, and can provide&#xD;
      information about the dynamic change of tracer metabolism and distribution in tissues with&#xD;
      time, so that it can provide more metabolic and distribution details of tumor lesions and&#xD;
      metastatic lesions than static scanning.At present, many studies have shown that&#xD;
      &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT early dynamic imaging technology can effectively improve the&#xD;
      sensitivity of hepatocellular carcinoma ,renal cell carcinoma and other tumors.More&#xD;
      amazing，there may be more advantages in evaluating lymph node metastasis.The blood supply of&#xD;
      lymph nodes metastatic of thyroid papillary carcinoma is abundant, which helps to locate the&#xD;
      metastatic tumor lymph node.However，there is no relevant study.Now , investigators plan to&#xD;
      observe the significance of the method to evaluate the central lymph node metastasis in&#xD;
      thyroid papillary carcinoma as well as the intrinsic correlations between the significance&#xD;
      and postoperative pathological results ,which may help to develop surgical strategy by&#xD;
      preoperative evaluation and avoiding additional dissection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of lymph nodes dissected</measure>
    <time_frame>12 months</time_frame>
    <description>Count the number of lymph nodes dissected during operation of every Participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants diagnosed with lymph node metastasis by &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans.</measure>
    <time_frame>12 months</time_frame>
    <description>Count the number of Participants diagnosed with lymph node metastasis by &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants diagnosed with lymph node metastasis by Postoperative pathology</measure>
    <time_frame>12 months</time_frame>
    <description>Count the number of Participants diagnosed with lymph node metastasis by Postoperative pathology.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of lymph node metastases in patients with different Genetic types</measure>
    <time_frame>12 months</time_frame>
    <description>To count the number of lymph node metastases in patients with different Genetic types basing on genetic testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculating the overall diagnostic sensitivity of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans</measure>
    <time_frame>12 months</time_frame>
    <description>Calculating the overall diagnostic sensitivity based on the results of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans and Postoperative pathology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculating the overall diagnostic specificity of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans</measure>
    <time_frame>12 months</time_frame>
    <description>Calculating the overall diagnostic specificity based on the results of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans and Postoperative pathology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculating the receiver operating characteristic curve（ROC）</measure>
    <time_frame>12 months</time_frame>
    <description>Calculate receiver operating characteristic curve（ROC） based on sensitivity and specificity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculating the radionics indicators of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT</measure>
    <time_frame>12 months</time_frame>
    <description>Based on the results above,to calculate the radionics indicators of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans in detecting metastatic central lymph nodes in participants with papillary thyroid cancer .</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Positron-Emission Tomography</condition>
  <condition>Lymph Node Metastases</condition>
  <condition>Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>&lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scan,Pathological examination and gene detection Diagnostic Test: &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scan The purpose of this study is to carry out &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B-ultrasonography group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>B-ultrasonography,Pathological examination and gene detection Diagnostic Test:B-ultrasonography The purpose of this study is to carry out &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>&lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scan</intervention_name>
    <description>The purpose of this study is to carry out &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.</description>
    <arm_group_label>&lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>B-ultrasonography</intervention_name>
    <description>The purpose of this study is to carry out &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of &lt;Sup&gt;18&lt;Sup&gt;F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.</description>
    <arm_group_label>B-ultrasonography group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Accurately diagnosing primary papillary thyroid cancer according to pathological&#xD;
             diagnostic criteria .&#xD;
&#xD;
               -  Thyroid papillary carcinoma was suspected by thyroid ultrasound text and/or neck&#xD;
                  CT.&#xD;
&#xD;
               -  The age is more than 18 years old and less than 65 years old. There is no gender&#xD;
                  restriction.&#xD;
&#xD;
               -  Untreated patients who have not received surgery, interventional&#xD;
                  therapy,chemotherapy, biotherapy, and radiation therapy.&#xD;
&#xD;
               -  Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no&#xD;
                  major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white&#xD;
                  blood cell count≥ 4 × 109/L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5&#xD;
                  × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the&#xD;
                  upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal&#xD;
                  value; and creatinine clearance ≥ 60ml / min.&#xD;
&#xD;
               -  Be able to obtain complete follow-up information, understand the situation of&#xD;
                  this study and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Poorly controlled diabetics (fasting blood glucose levels &gt; 200 mg/dL).• In addition&#xD;
             to four types of malignant tumors that can be treated with radical resection, such as&#xD;
             cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma&#xD;
             in situ, and organ localized prostate cancer, suffering from any other malignant&#xD;
             tumors within 5 years.• Breastfeeding and/or pregnant women.&#xD;
&#xD;
               -  Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot&#xD;
                  be corrected by treatment with vitamin K, etc.).&#xD;
&#xD;
               -  Recent severe hemoptysis, severe cough, dyspnea or patients are not able to&#xD;
                  cooperate.&#xD;
&#xD;
               -  People with severe emphysema, pulmonary congestion, and pulmonary heart disease.&#xD;
&#xD;
               -  Researchers believe that the subject may not be able to complete this study or&#xD;
                  may not be able to comply with the requirements of this study (for management&#xD;
                  reasons or other reasons).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hongjun Jin, doctor</last_name>
    <phone>0756-2526136</phone>
    <email>jinhj3@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qingan Zeng, master</last_name>
    <phone>0756-2528810</phone>
    <email>1056555022@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fifth Affiliated Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongjun JIN, doctor</last_name>
      <phone>0756-2526136</phone>
      <email>jinhj3@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fifth Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Hongjun Jin</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>Thyroid Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03830242
org study id: ZDWY.JRWK.001
nct id: NCT03830242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to make up for the gap by performing a dynamic scan of
      <Sup>18<Sup>F-FDG PET/CT on newly diagnosed patients with papillary thyroid carcinoma.
      Pathological and genomic studies are performed. The differences between metastatic central
      lymph nodes images and tissues are compared at the same time. <Sup>18<Sup>F-FDG PET/CT
      dynamic imaging is explored in metastatic central lymph nodes with papillary thyroid cancer
      for the diagnostic value.
Thyroid cancer is the most common malignant tumor in human endocrine system, accounting for
      0.2% ~ 1.0% of malignant tumors .According to the global cancer report released by the world
      health organization (WHO) in 2014, 50% of the new cases of thyroid cancer are papillary
      thyroid cancer (PTC). In recent years, the incidence of thyroid cancer in China shows an
      increasing trend, especially the composition ratio of thyroid micro-papillary carcinoma with
      the focal diameter <1 cm increases rapidly.Although PTC has a good prognosis, according to a
      Meta analysis , PTC lymph node metastasis rate is as high as 28.0%.The central lymph node is
      the most common metastatic site of papillary thyroid carcinoma.In addition, it has been
      reported in literature that lymph nodes in the central region are the first stop of thyroid
      papillary carcinoma metastasis (i.e., sentinel lymph nodes), and lymph nodes metastatic to
      this point are prone to infringe the peripheral esophagus, trachea and recurrent laryngeal
      nerve at an early stage.A large number of clinical cases have confirmed that lymph node
      metastasis of thyroid cancer significantly increases the local recurrence rate after
      surgery.More studies have shown that regional lymph node metastasis increases
      mortality.Therefore, the treatment of lymph node metastasis should not be ignored in PTC
      patients.However, at present, preoperative imaging has certain limitations in the judgment of
      lymph node metastasis in the central region : ultrasound has advantages in the judgment of
      lymph node metastasis in the peripheral group, but poor display in the central group.Although
      MRI scan of head and neck can be multi-directional and multi-sequence imaging, and the
      resolution of soft tissue is high, it is not good at showing calcification.Conventional CT
      alone based on lymph node morphology to determine metastasis also has some
      limitations;Positron emission tomography (PET) sensitivity was < 40%.Although one study
      showed that the probability of non-missed diagnosis of lymph nodes in central PTC region by
      thin slice CT scan was 100%, the specificity was low and the study was
      retrospective.Therefore, b-ultrasound, MRI, CT, PET and other auxiliary examinations have not
      been able to effectively detect all central metastatic lymph nodes before surgery.For
      management of cervical lymph nodes ,2015 American Thyroid Association（ATA） guidelines show
      that thyroid+therapeutic Ⅵ area lymph node dissection should be undertaken if in central or
      lateral lymph nodes are involved.Chinese guidelines recommend that, in order to avoid
      operative complications as far as possible (i.e. effective retainment of the parathyroid
      gland and recurrent laryngeal nerve), regardless of the size of the primary thyroid lesion,
      lymph node dissection in the central area on the same side of the lesion should be performed
      at least.However, in 2017, the second edition of National Comprehensive Cancer Network(NCCN)
      thyroid tumor guidelines believed that if lymph nodes in the central region were negative,
      preventive central region lymph node dissection was not recommended.Above all，there is so
      much controversy over lymph node dissection in the central region. Therefore，it is of great
      significance to effectively evaluate the preoperative lymph nodes station in the central
      region of thyroid papillary carcinoma.

      Early dynamic imaging examination of <Sup>18<Sup>F-FDG PET/CT can be defined as a imaging
      method to detect the status of radioactive tracer (<Sup>18<Sup>F-FDG) which travels with the
      blood flow and is continuously absorbed and excreted by organs (or diseased) tissues after
      being introduced into the body in the early stage.This development reflects the change of
      <Sup>18<Sup>F-FDG activity with time in the early stage of entering the body, and can provide
      information about the dynamic change of tracer metabolism and distribution in tissues with
      time, so that it can provide more metabolic and distribution details of tumor lesions and
      metastatic lesions than static scanning.At present, many studies have shown that
      <Sup>18<Sup>F-FDG PET/CT early dynamic imaging technology can effectively improve the
      sensitivity of hepatocellular carcinoma ,renal cell carcinoma and other tumors.More
      amazing，there may be more advantages in evaluating lymph node metastasis.The blood supply of
      lymph nodes metastatic of thyroid papillary carcinoma is abundant, which helps to locate the
      metastatic tumor lymph node.However，there is no relevant study.Now , investigators plan to
      observe the significance of the method to evaluate the central lymph node metastasis in
      thyroid papillary carcinoma as well as the intrinsic correlations between the significance
      and postoperative pathological results ,which may help to develop surgical strategy by
      preoperative evaluation and avoiding additional dissection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Number of lymph nodes dissected
time frame: 12 months
description: Count the number of lymph nodes dissected during operation of every Participants.
measure: Number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.
time frame: 12 months
description: Count the number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.
measure: Number of Participants diagnosed with lymph node metastasis by Postoperative pathology
time frame: 12 months
description: Count the number of Participants diagnosed with lymph node metastasis by Postoperative pathology.
measure: The number of lymph node metastases in patients with different Genetic types
time frame: 12 months
description: To count the number of lymph node metastases in patients with different Genetic types basing on genetic testing.
measure: Calculating the overall diagnostic sensitivity of <Sup>18<Sup>F-FDG PET/CT dynamic scans
time frame: 12 months
description: Calculating the overall diagnostic sensitivity based on the results of <Sup>18<Sup>F-FDG PET/CT dynamic scans and Postoperative pathology.
measure: Calculating the overall diagnostic specificity of <Sup>18<Sup>F-FDG PET/CT dynamic scans
time frame: 12 months
description: Calculating the overall diagnostic specificity based on the results of <Sup>18<Sup>F-FDG PET/CT dynamic scans and Postoperative pathology.
measure: Calculating the receiver operating characteristic curve（ROC）
time frame: 12 months
description: Calculate receiver operating characteristic curve（ROC） based on sensitivity and specificity.
measure: Calculating the radionics indicators of <Sup>18<Sup>F-FDG PET/CT
time frame: 12 months
description: Based on the results above,to calculate the radionics indicators of <Sup>18<Sup>F-FDG PET/CT dynamic scans in detecting metastatic central lymph nodes in participants with papillary thyroid cancer .
arm group label: <Sup>18<Sup>F-FDG PET/CT study group
arm group type: Experimental
description: <Sup>18<Sup>F-FDG PET/CT dynamic scan,Pathological examination and gene detection Diagnostic Test: <Sup>18<Sup>F-FDG PET/CT dynamic scan The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
arm group label: B-ultrasonography group
arm group type: Other
description: B-ultrasonography,Pathological examination and gene detection Diagnostic Test:B-ultrasonography The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
intervention type: Diagnostic Test
intervention name: <Sup>18<Sup>F-FDG PET/CT dynamic scan
description: The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
arm group label: <Sup>18<Sup>F-FDG PET/CT study group
intervention type: Diagnostic Test
intervention name: B-ultrasonography
description: The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
arm group label: B-ultrasonography group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hongjun Jin, doctor
phone: 0756-2526136
email: jinhj3@mail.sysu.edu.cn
last name: Qingan Zeng, master
phone: 0756-2528810
email: 1056555022@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fifth Affiliated Hospital, Sun Yat-Sen University
investigator full name: Hongjun Jin
investigator title: principal Investigator
mesh term: Thyroid Neoplasms
mesh term: Lymphatic Metastasis
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases
sharing ipd: Undecided