Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer
NCT Number: NCT06498674
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Thyroid Cancer
Interventions: DIAGNOSTIC_TEST: Supplementary Pathological Examination|OTHER: No Need for Supplementary Pathological Examination
Sponsor: Fujian Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2025-06-30
Locations: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China

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.

Primary Outcome Measures: Supplementary Pathological Examination, For patients who have completed traditional two-dimensional color ultrasound and AI-assisted ultrasound, record whether a supplementary pathological examination was conducted., One day after surgery|Change in Treatment Decision, 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., One day after surgery
Secondary Outcome Measures: Traditional Two-Dimensional Color Ultrasound Findings, 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., Preoperative|AI-Assisted Ultrasound Interpretation Results, 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., Preoperative|Supplementary Pathological Examination Results, For patients who underwent supplementary pathological examination, record the results of their pathological examination., One day Postoperative|Postoperative Pathology Report, Record the presence of thyroid lesions and lymph node metastasis in the postoperative pathology report., One day after the postoperative pathology report is released|Statistical Indicators, 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, One day after the postoperative pathology report is released|Statistical Indicator missed diagnosis rate., 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., One day after the postoperative pathology report is released|Statistical Indicator positive predictive value, Using pathological evidence as the gold standard positive predictive value, One day after the postoperative pathology report is released|Statistical Indicator Youden index, Using pathological evidence as the gold standard Youden index., One day after the postoperative pathology report is released