Artificial Intelligence-assisted Contrast-enhanced Ultrasound Diagnosis of Thyroid Nodules (AIA-CEUD-TN)

Sun Yat-sen University

Status: Completed

Conditions: Thyroid Nodule

Treatments: Other: Artificial Intelligence

Study type: Interventional

Funder types: Other

Identifiers

NCT05982821

SYSKY-2023-702-01

Details and patient eligibility

About

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.

Enrollment: 1,955 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,955 participants in 1 patient group

Test set

Other group

Description:

Participants with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2021 and December 2022 in Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Houjie Hospital of Dongguan and Affiliated Huadu Hospital of Southern Medical University.

Treatment:

Other: Artificial Intelligence