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COMPLETED
NCT06498674
NA

AI-Assisted Ultrasound Review Before Thyroid Surgery

Sponsor: Fujian Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

515

Start Date

2024-09-01

Completion Date

2025-10-15

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review

After standard preoperative ultrasonography, the same participant underwent a standardized AI-assisted repeat examination. The locked system identified and classified thyroid nodules and provided malignancy-score information for surgeon-led review. It did not assess cervical lymph nodes and was not retrained or recalibrated during the study. Additional fine-needle aspiration, intraoperative pathologic examination, and surgical management were determined by clinicians using the complete clinical assessment.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China