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Completed NCT06498674

AI-Assisted Ultrasound Review Before Thyroid Surgery

Conditions: Thyroid Cancer, Thyroid Nodule

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 515
Sponsor: Fujian Medical University

Location: Fujian Medical University Union Hospital Fuzhou Fujian

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06498674). StuddyBuddy aggregates publicly available trial information.