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

NCT03830242 | Unknown

• 1 other identifier: ZDWY.JRWK.001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Positron-Emission Tomography; Lymph Node Metastases; Thyroid Cancer

Outcome Measures

Primary Outcomes (4)

• Number of lymph nodes dissected

  Count the number of lymph nodes dissected during operation of every Participants.

  12 months

• Number of Participants diagnosed with lymph node metastasis by <Sup>18<Sup>F-FDG PET/CT dynamic scans.

  Count the number of Participants diagnosed with lymph node metastasis by \<Sup\>18\<Sup\>F-FDG PET/CT dynamic scans.

  12 months

• Number of Participants diagnosed with lymph node metastasis by Postoperative pathology

  Count the number of Participants diagnosed with lymph node metastasis by Postoperative pathology.

  12 months

• The number of lymph node metastases in patients with different Genetic types

  To count the number of lymph node metastases in patients with different Genetic types basing on genetic testing.

  12 months

Secondary Outcomes (4)

• Calculating the overall diagnostic sensitivity of <Sup>18<Sup>F-FDG PET/CT dynamic scans

  12 months

• Calculating the overall diagnostic specificity of <Sup>18<Sup>F-FDG PET/CT dynamic scans

  12 months

• Calculating the receiver operating characteristic curve（ROC）

  12 months

• Calculating the radionics indicators of <Sup>18<Sup>F-FDG PET/CT

  12 months

Study Arms (2)

<Sup>18<Sup>F-FDG PET/CT study group

EXPERIMENTAL

\<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

B-ultrasonography group

OTHER

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

Interventions

<Sup>18<Sup>F-FDG PET/CT dynamic scan DIAGNOSTIC_TEST

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.

<Sup>18<Sup>F-FDG PET/CT study group

B-ultrasonography DIAGNOSTIC_TEST

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.

B-ultrasonography group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Fifth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lymphatic Metastasis; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Hongjun Jin, doctor

CONTACT

0756-2526136; jinhj3@mail.sysu.edu.cn

Qingan Zeng, master

CONTACT

0756-2528810; 1056555022@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: February 5, 2019
• Study Start: November 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

CN (1)