NCT07296575Active, not recruiting
Ultrasound Large-scale Model in Thyroid Field: A Multi-center Study on Medical-Engineering Integration
A Multicenter Study on Multimodal Diagnosis and Process Optimization of Thyroid Diseases Based on Ultrasonic Intelligent Agents
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
The goal of this observational study is to evaluate the diagnostic accuracy and clinical workflow integration of an ultrasound intelligent agent (UIA) for thyroid disease management in a real-world multicenter setting. The primary research question is: Can the UIA improve diagnostic consistency and efficiency for thyroid nodules (TI-RADS 1-5), Hashimoto's thyroiditis, and cervical lymph node metastasis compared to traditional ultrasound interpretation? Participants will include adults (18-80 years) undergoing thyroid ultrasound at 16 participating hospitals across China. Key inclusion criteria cover patients with suspected thyroid disorders requiring imaging, while exclusion criteria address poor image quality or concurrent clinical trials. Over 2,000 cases (50% thyroid nodules, 30% diffuse lesions, 12.5% non-nodular abnormalities, 7.5% special populations) will be prospectively enrolled. Data collection integrates static/dynamic ultrasound images, laboratory results, and AI-generated reports. Primary endpoints include model performance metrics (AUC, sensitivity/specificity, TI-RADS Kappa ≥0.8), workflow efficiency (report generation time ≤5 minutes), and pediatric/pregnancy-specific reference standards. Secondary analyses will assess inter-rater reliability (Cohen's Kappa) and longitudinal outcomes via 6-12-month follow-up. This study aims to establish evidence-based guidelines for AI-augmented thyroid diagnosis, particularly in underserved regions, while addressing gaps in current AI validation frameworks related to multi-modality data fusion and special population adaptability.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 7 Dec 2025
- Start date
- Oct 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Diseases
- Thyroid cancer, Childhood cancers
- NCT number
- NCT07296575
What you commit to
- Study type: Observational
- Planned participants: 2000
- From Oct 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior participation in other thyroid ultrasound-related clinical trials; postoperative thyroid recurrence;
Other illness
- Inability to cooperate with examination (consciousness impairment, extreme non-compliance);
Other
- Poor image quality (severe gas interference, artifacts obscuring structural visualization);
- Thyroid malformation/ectopia affecting visualization.
Who the study is looking for
- Ages 18-80, clinically suspected thyroid disease (e.g., enlargement, nodules, pain) requiring ultrasound examination;
- Diffuse lesions must demonstrate both ultrasound characteristics and laboratory evidence;
- Dynamic video must fully cover the maximum diameter of the nodule without significant probe movement;
- Voluntary signed informed consent.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.