CompletedNot Applicable

Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules

China1,955 participantsStarted 2023-06-03

Plain-language summary

The goal of this intervention study is to learn about the diagnostic performance of artificial intelligence to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules. The main questions it aims to answer are: 1. Can we develop an artificial intelligence model to assist the contrast-enhanced ultrasound diagnosis of thyroid nodules? 2. Can artificial intelligent reduce the unnecessary biopsy of thyroid nodules? Participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. Researchers will calculate the diagnostic performance of the contrast-enhanced ultrasound diagnosis of thyroid nodules with and without artificial intelligent assistance.

Who can participate

Age range

18 Years

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 thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound; * Patients who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy; * Patients with a final benign or malignant pathological results. Exclusion Criteria: * Patients with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology； * Patients with a history of thyroid ablation or surgery; * Patients with low-quality ultrasound images.

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

Diagnostic performance

Timeframe: First week after primary completion date.

The necessity of biopsy

Timeframe: First week after primary completion date.

Trial details

NCT IDNCT05982821

SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-02

View on ClinicalTrials.gov More Thyroid Nodule trials