Thyroid Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | Fifth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Fifth Affiliated Hospital, Sun Yat-Sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of lymph nodes dissected | Count the number of lymph nodes dissected during operation of every Participants. | 12 months | |
Primary | 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
12 months |
| |
Primary | 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 | |
Primary | 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 | Calculating the overall diagnostic sensitivity of <Sup>18<Sup>F-FDG PET/CT dynamic scans | Calculating the overall diagnostic sensitivity based on the results of
12 months |
| |
Secondary | Calculating the overall diagnostic specificity of <Sup>18<Sup>F-FDG PET/CT dynamic scans | Calculating the overall diagnostic specificity based on the results of
12 months |
| |
Secondary | Calculating the receiver operating characteristic curve(ROC) | Calculate receiver operating characteristic curve(ROC) based on sensitivity and specificity. | 12 months | |
Secondary | Calculating the radionics indicators of <Sup>18<Sup>F-FDG PET/CT | Based on the results above,to calculate the radionics indicators of
12 months |
| |
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