Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer
- Conditions
- Thyroid Cancer
- Interventions
- Diagnostic Test: Supplementary Pathological ExaminationOther: No Need for Supplementary Pathological Examination
- Registration Number
- NCT06498674
- Lead Sponsor
- Fujian Medical University
- Brief Summary
This study aims to explore the application of AI-assisted ultrasound technology in the preoperative assessment of thyroid cancer. Traditional ultrasound examination data from thyroid cancer patients will be collected, and AI systems will be utilized to detect and diagnose thyroid nodules and lymph nodes. In cases where there is disagreement between the two-dimensional ultrasound and AI system results, further confirmation will be sought through biopsy. Subsequently, pathological results will serve as the "gold standard" for comparison between the AI system and traditional ultrasound examination results, assessing their accuracy and reliability. Through this research endeavor, a more accurate and reliable method for preoperative assessment of thyroid cancer is aspired to be offered, thereby supporting clinical decision-making and paving the way for novel applications of AI in the field of medical imaging diagnosis.
- Detailed Description
This study aims to investigate the application of AI-assisted ultrasound technology in the preoperative assessment of thyroid cancer. Traditional ultrasound examination data from patients with thyroid cancer, including two-dimensional ultrasound images, color Doppler flow images, and detailed characteristics of thyroid nodules and lymph nodes such as number, size, morphology, echogenicity, margins, calcifications, and aspect ratio, will be collected. Prior to surgery, a reassessment will be conducted using AI-assisted ultrasound technology, and the detection and diagnostic results of thyroid nodules and lymph nodes by the AI system will be recorded. In cases where there is discrepancy between the results of two-dimensional ultrasound and the AI system, fine needle aspiration biopsy or intraoperative biopsy will be performed for further confirmation of their nature. Post-surgery, the pathological results of each nodule will serve as the "gold standard" for comparative analysis between the AI system and traditional two-dimensional ultrasound examinations. The accuracy of the AI system in detecting and localizing nodules will be analyzed, and its sensitivity, specificity, and accuracy will be calculated to evaluate its diagnostic efficacy and reliability in the preoperative assessment of thyroid cancer. Through this research, a more accurate and reliable adjunctive diagnostic method for the preoperative assessment of thyroid cancer is aimed to be provided to assist clinical decision-making. Additionally, new avenues and directions for the application of AI in the field of medical imaging diagnosis will be explored.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Discordant Group Supplementary Pathological Examination Patients in whom the detection and diagnostic results of thyroid nodules and lymph nodes differ between traditional two-dimensional ultrasound and AI-assisted ultrasound. Concordant Group No Need for Supplementary Pathological Examination Patients in whom the detection and diagnostic results of thyroid nodules and lymph nodes are consistent between traditional two-dimensional ultrasound and AI-assisted ultrasound.
- Primary Outcome Measures
Name Time Method Change in Treatment Decision 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 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.
- Secondary Outcome Measures
Name Time Method Statistical Indicator positive predictive value One day after the postoperative pathology report is released Using pathological evidence as the gold standard positive predictive value
AI-Assisted Ultrasound Interpretation Results Preoperative Record ultrasound image features such as number, size, morphology, echogenicity, margins, calcifications, and TI-RADS score of thyroid nodules and lymph nodes under AI-assisted ultrasound.
Statistical Indicator missed diagnosis rate. One day after the postoperative pathology report is released Using pathological evidence as the gold standard, construct contingency tables for both preoperative traditional two-dimensional color ultrasound and AI-assisted ultrasound, missed diagnosis rate.
Supplementary Pathological Examination Results One day Postoperative For patients who underwent supplementary pathological examination, record the results of their pathological examination.
Statistical Indicator Youden index One day after the postoperative pathology report is released Using pathological evidence as the gold standard Youden index.
Traditional Two-Dimensional Color Ultrasound Findings Preoperative Record ultrasound image features such as number, size, morphology, echogenicity, margins, calcifications, and TI-RADS score of thyroid nodules and lymph nodes under traditional two-dimensional color ultrasound.
Postoperative Pathology Report One day after the postoperative pathology report is released Record the presence of thyroid lesions and lymph node metastasis in the postoperative pathology report.
Statistical Indicators One day after the postoperative pathology report is released Using pathological evidence as the gold standard, construct contingency tables for both preoperative traditional two-dimensional color ultrasound and AI-assisted ultrasound, calculate sensitivity, specificity
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China