Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Change in Treatment Decision
研究概览
简要总结
This prospective, single-center, single-arm study evaluates a locked artificial intelligence (AI) system as a surgeon-led second-read tool before thyroid surgery. Eligible participants scheduled for thyroid surgery undergo standard ultrasonography followed by a standardized AI-assisted repeat examination. The AI system evaluates thyroid nodules only; cervical lymph nodes are assessed by clinicians. The study assesses participant-level supplementary pathological examinations and treatment-decision changes and evaluates nodule-level diagnostic performance against final surgical histopathology.
详细描述
This prospective, single-center, single-arm study evaluates a locked AI-assisted ultrasound system used during surgeon-led preoperative review in participants scheduled for thyroid surgery. Each participant undergoes standard preoperative ultrasonography followed by a standardized AI-assisted repeat examination. The locked system provides thyroid-nodule malignancy scores and classifications; it was not retrained or recalibrated during the study and did not assess cervical lymph nodes. Clinicians integrate standard ultrasound, cytology, clinical findings, and other information and retain responsibility for all supplementary examinations and final management decisions. The two primary outcomes are participant-level: (1) whether a participant undergoes an additional cytologic or pathologic examination and (2) whether a participant has at least one change in planned surgical management. Participants are counted once within each outcome, while event counts may be summarized separately. The embedded diagnostic analysis is nodule-level and uses unambiguously pathology-matched surgical histopathology as the reference standard. Only nodules with a definitive benign or malignant surgical histopathological diagnosis are included in binary diagnostic-performance calculations. Low-risk or borderline thyroid neoplasms, including follicular tumors of uncertain malignant potential (FT-UMP), well-differentiated tumors of uncertain malignant potential (WDT-UMP), and non-invasive follicular thyroid neoplasms with papillary-like nuclear features (NIFTP), and nodules without unambiguous lesion-level linkage are excluded from binary reference-standard analyses. These post-enrollment analysis exclusions do not alter the 515-participant actual enrollment or the participant-level workflow cohort. A participant may contribute another eligible nodule if that lesion has an unambiguous definitive diagnosis. Cervical lymph-node pathology is described only for nodes actually removed or sampled; no reference diagnosis is assigned to unsampled nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with preoperative pathological confirmation of thyroid malignant tumors undergoing surgical treatment.
- •Patients with benign thyroid tumors, such as thyroid adenomas causing compressive symptoms, undergoing surgical treatment.
- •Patients with complete and high-quality traditional two-dimensional color ultrasound images.
- •Complete postoperative pathology reports.
- •Willingness to participate in this clinical trial and signing of informed consent.
排除标准
- •Patients with a history of neck surgery or radiotherapy.
- •Patients with a history of malignant tumors in other parts of the body.
- •Patients with thyroid dysfunction.
- •Incomplete or poor-quality traditional two-dimensional color ultrasound images.
- •Incomplete postoperative pathology reports.
- •Refusal to participate in this clinical trial.
研究组 & 干预措施
AI-Assisted Preoperative Review
Participants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output. The AI system does not assess cervical lymph nodes. All supplementary examinations and final diagnostic and surgical decisions are made by clinicians.
干预措施: Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review (Diagnostic Test)
结局指标
主要结局
Change in Treatment Decision
时间窗: One day after surgery
For patients who have completed traditional two-dimensional color ultrasound, AI-assisted ultrasound, and undergone supplementary pathological examination, record whether there was a change in the surgical approach or scope.
Supplementary Pathological Examination
时间窗: One day after surgery
For patients who have completed traditional two-dimensional color ultrasound and AI-assisted ultrasound, record whether a supplementary pathological examination was conducted.
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
时间窗: From completion of the AI-assisted repeat examination through completion of surgery
Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery. Each participant is counted once regardless of the number of examinations. The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
Proportion of Participants With a Change in Planned Surgical Management
时间窗: From completion of the AI-assisted review through surgery
Number and proportion of enrolled participants with at least one documented change in the surgeon-led planned surgical approach or extent after conventional ultrasonography, AI-assisted review, and any supplementary pathological examination, when performed. Changes may involve thyroid resection or cervical lymph-node management. Each participant is counted once regardless of the number of changes. The AI system provided thyroid-nodule information only and did not assess cervical lymph nodes.
次要结局
- Statistical Indicator positive predictive value(One day after the postoperative pathology report is released)
- AI-Assisted Ultrasound Interpretation Results(Preoperative)
- Statistical Indicator missed diagnosis rate.(One day after the postoperative pathology report is released)
- Supplementary Pathological Examination Results(One day Postoperative)
- Statistical Indicator Youden index(One day after the postoperative pathology report is released)
- Traditional Two-Dimensional Color Ultrasound Findings(Preoperative)
- Postoperative Pathology Report(One day after the postoperative pathology report is released)
- Statistical Indicators(One day after the postoperative pathology report is released)
- Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules(During standard preoperative ultrasonography, before the AI-assisted repeat examination)
- Proportion of Evaluated Thyroid Nodules Classified as AI-Positive(During the preoperative AI-assisted repeat examination, before surgery)
- Results of Supplementary Cytologic or Pathologic Examinations(From supplementary sampling to availability of the corresponding result, before or during surgery)
- Final Histopathological Diagnosis of Resected Thyroid Nodules(From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level Sensitivity of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level False-Negative Rate of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level Positive Predictive Value of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level Youden Index of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Distribution of Cervical Lymph-Node Metastasis Status Among Pathologically Examined Nodes(From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level Specificity of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level Negative Predictive Value of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Nodule-Level Accuracy of AI and C-TIRADS(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
- Area Under the ROC Curve for the Continuous AI Malignancy Score(From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.)
研究者
Bo Wang,MD
Director and Head of Thyroid Surgery; Principal Investigator; Clinical Professor
Fujian Medical University