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Diagnostic Significance of FDG PET/CT Dynamic Imaging in Detecting Metastatic Lymph Nodes With Papillary Thyroid Cancer.

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ClinicalTrials.gov Identifier: NCT03830242
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hongjun Jin, Fifth Affiliated Hospital, Sun Yat-Sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Positron-Emission Tomography Lymph Node Metastases Thyroid Cancer Diagnostic Test: <Sup>18<Sup>F-FDG PET/CT dynamic scan Diagnostic Test: B-ultrasonography Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging in Detecting Metastatic Central Lymph Nodes in Patients With Papillary Thyroid Cancer
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Experimental: <Sup>18<Sup>F-FDG PET/CT study group
<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.
 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.
B-ultrasonography group
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of lymph nodes dissected [ Time Frame: 12 months ]
    Count the number of lymph nodes dissected during operation of every Participants.

  2. Number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans. [ Time Frame: 12 months ]
    Count the number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.

  3. Number of Participants diagnosed with lymph node metastasis by Postoperative pathology [ Time Frame: 12 months ]
    Count the number of Participants diagnosed with lymph node metastasis by Postoperative pathology.

  4. The number of lymph node metastases in patients with different Genetic types [ Time Frame: 12 months ]
    To count the number of lymph node metastases in patients with different Genetic types basing on genetic testing.


Secondary Outcome Measures :
  1. Calculating the overall diagnostic sensitivity of <Sup>18<Sup>F-FDG PET/CT dynamic scans [ Time Frame: 12 months ]
    Calculating the overall diagnostic sensitivity based on the results of <Sup>18<Sup>F-FDG PET/CT dynamic scans and Postoperative pathology.

  2. Calculating the overall diagnostic specificity of <Sup>18<Sup>F-FDG PET/CT dynamic scans [ Time Frame: 12 months ]
    Calculating the overall diagnostic specificity based on the results of <Sup>18<Sup>F-FDG PET/CT dynamic scans and Postoperative pathology.

  3. Calculating the receiver operating characteristic curve（ROC） [ Time Frame: 12 months ]
    Calculate receiver operating characteristic curve（ROC） based on sensitivity and specificity.

  4. Calculating the radionics indicators of <Sup>18<Sup>F-FDG PET/CT [ Time Frame: 12 months ]
    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 .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Accurately diagnosing primary papillary thyroid cancer according to pathological diagnostic criteria .

    • Thyroid papillary carcinoma was suspected by thyroid ultrasound text and/or neck CT.
    • The age is more than 18 years old and less than 65 years old. There is no gender restriction.
    • Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy.
    • Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min.
    • Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent.

Exclusion Criteria:

  • • Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL).• In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women.

    • Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.).
    • Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate.
    • People with severe emphysema, pulmonary congestion, and pulmonary heart disease.
    • Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830242


Contacts
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Contact: Hongjun Jin, doctor 0756-2526136 jinhj3@mail.sysu.edu.cn
Contact: Qingan Zeng, master 0756-2528810 1056555022@qq.com

Locations
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China, Guangdong
Fifth Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Hongjun JIN, doctor    0756-2526136    jinhj3@mail.sysu.edu.cn   
Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Hongjun Jin, principal Investigator, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03830242    
Other Study ID Numbers: ZDWY.JRWK.001
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Lymphatic Metastasis
Thyroid Cancer, Papillary
Thyroid Diseases
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine System Diseases
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type