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

A Multicenter Study of Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05982821

Acronym

AIA-CEUD-TN

Enrollment

1955

Registered

2023-08-09

Start date

2023-06-03

Completion date

2026-03-16

Last updated

2026-03-25

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

Conditions

Thyroid Nodule

Keywords

Artificial interligence, Contrast media, diagnosis, Thyroid nodule, Ultrasonography

Brief 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.

Interventions

OTHERArtificial Intelligence

Artificial intelligence assisted contrast-enhanced ultrasound diagnosis of thyroid nodules.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

Cytopathologists, histopathologists and statistical analysts were blinded to the intervention.

Intervention model description

A deep-learning based artificial intelligence model.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance	First week after primary completion date.	Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, area under the curve
The necessity of biopsy	First week after primary completion date.	Unnecessary biopsy rate

Countries

China

Contacts

PRINCIPAL_INVESTIGATORJingliang Ruan, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026