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Artificial Intelligence Based on Multimodal Ultrasound for Malignancy Risk Assessment of TI-RADS 3–5 Thyroid Nodules: A Multicenter Study

Artificial Intelligence Based on Multimodal Ultrasound for Malignancy Risk Assessment of TI-RADS 3–5 Thyroid Nodules: A Multicenter Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126962
Enrollment
Unknown
Registered
2026-06-22
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Interventions

Training Set:None
Test/Validation Set:None

Sponsors

Xijing Hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Retrospective study: Data of patients aged 18 and above were collected from January 2022 to November 2025. Two-dimensional gray-scale ultrasound examination detected thyroid nodules and diagnosed them as C-TIRADS3-5. There are contrast-enhanced ultrasound examinations within one month, transient elastography examinations, and conventional gray-scale ultrasound examinations. There were three months of ultrasound-guided fine-needle aspiration or surgery, and pathological results were obtained. 2. Prospective study: Data of patients aged 18 and above were collected from December 2025 to June 2026. Two-dimensional gray-scale ultrasound examination detected thyroid nodules and diagnosed them as C-TIRADS3-5. Contrast-enhanced ultrasound examination, transient elastography examination and conventional gray-scale ultrasound examination should be performed within one month. Ultrasound-guided fine-needle aspiration or surgery must be performed within three months to obtain pathological results.

Exclusion criteria

Exclusion criteria: 1. Poor image quality on two-dimensional grayscale ultrasound, elastography, or contrast-enhanced ultrasound; 2. Inconclusive histopathological or cytological results; 3. Prior history of thyroid surgery.

Design outcomes

Primary

MeasureTime frame
Accuracy, sensitivity, and specificity of artificial intelligence methods compared with C-TIRADS traditional methods and histopathology;

Secondary

MeasureTime frame
Interobserver agreement among junior and senior ultrasound physicians using artificial intelligence assistance;

Countries

China

Contacts

Public ContactLuo Wen

Xijing Hospital, Air Force Medical University

lwdd1234@fmmu.edu.cn+86 150 2905 8962

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026