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