Clinical trial · Interventional
AI-Assisted Ultrasound Review Before Thyroid Surgery
Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AI-Assisted Preoperative Review
- description
- Participants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output. The AI system does not assess cervical lymph nodes. All supplementary examinations and final diagnostic and surgical decisions are made by clinicians.
- interventionNames
- Diagnostic Test: Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review
Primary outcomes (2)
- measure
- Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
- timeFrame
- From completion of the AI-assisted repeat examination through completion of surgery
- description
- Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery. Each participant is counted once regardless of the number of examinations. The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available