AI-Assisted Ultrasound Review Before Thyroid Surgery (NCT06498674) | Clinical Trial Compass
CompletedNot Applicable
AI-Assisted Ultrasound Review Before Thyroid Surgery
China515 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
Timeframe: From completion of the AI-assisted repeat examination through completion of surgery
2
Proportion of Participants With a Change in Planned Surgical Management
Timeframe: From completion of the AI-assisted review through surgery