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临床试验/NCT06146764
NCT06146764招募中不适用

Contrast-enhanced Ultrasound Improves the Diagnostic Performance of Sonographic Risk Stratification System of Thyroid Carcinoma: Comparison Between Integrated Scoring Method and Up-and-down Scoring Method

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
Diagnostic performance

研究概览

简要总结

Contrast-enhanced ultrasound (CEUS) can sensitively show the blood perfusion characteristics of thyroid nodules, which is a useful supplement to gray-scale ultrasound. However, there is no standard combined diagnostic method of gray-scale ultrasound and CEUS. Therefore, the aim of this study was to compare the diagnostic performance of the integrated scoring method and the up-and-down scoring method. This study was a multicenter retrospective clinical study and followed the Standards for Reporting of Diagnostic Accuracy Studies (version 2015). Inclusion criteria: 1) participants with at least one thyroid nodule larger than 5 mm confirmed by conventional ultrasound; 2) participants underwent gray-scale ultrasound, contrast-enhanced ultrasound and fine needle aspiration biopsy of the thyroid nodule successively; 3) participants have a final diagnosis of benign or malignant. Exclusion criteria included: 1) participants with cytologic findings of Bethesda I, III, or IV without definitive benign or malignant pathologic findings; 2) participants with a history of thyroid fine needle aspiration, ablation or surgery; 3) participants with low quality ultrasound images (e.g., severe artifacts or low image resolution). According to the American College of Radiology Thyroid Imaging Reporting and Data System, only one thyroid nodule with the highest point was included in each participant. A total of 600 participants from January 2018 to December 2022 were consecutively included in Sun Yat-sen Memorial Hospital of Sun Yat-sen University to form a training set (average age 48 years; Range 24-81 years old). A total of 200 subjects with thyroid nodules from January 2022 to December 2022 were consecutively included to form an external validation set in Houjie Hospital of Dongguan City, Guangdong Province (mean age 46 years; Range 30-74 years). The malignant risk of enrolled thyroid nodules and the necessity of biopsy were evaluated by integrated scoring method and up-and-down scoring method, respectively. The diagnostic performance and unnecessary biopsy rate of the above two methods were calculated and compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound;
  • Participants who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy;
  • Participants with a final benign or malignant pathological results.

排除标准

  • Participants with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology;
  • Participants with a history of thyroid ablation or surgery;
  • Participants with low-quality ultrasound images.

结局指标

主要结局

Diagnostic performance

时间窗: First week after primary completion date

Sensitivity, specificity, positive predictive value, negative predictive value, area under the curve

Unnecessary biopsy rate

时间窗: First week after primary completion date

The unnecessary biopsy rate was defined as a percentage of the number of benign nodules among biopsy-indicated nodules in the total nodules.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingliang Ruan, PhD

Principal Investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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