Artificial Intelligent Accelerates the Learning Curve for Mastering Contrast-enhanced Ultrasound of Thyroid Nodules

Sun Yat-sen University

Status: Enrolling

Conditions: Thyroid Nodule

Treatments: Other: Artificial Intelligent

Study type: Observational

Funder types: Other

Identifiers

NCT05982821

SYSKY-2023-702-01

Details and patient eligibility

About

The goal of this observational study is to learn about the learning curve for mastering the thyroid imaging reporting and data system of contrast-enhanced ultrasound with the assistance of artificial intelligence in patients with thyroid nodules. The main questions it aims to answer are:

1. Can we develop a artificial intelligent software to assist doctors in the diagnosis of thyroid nodules using contrast-enhanced ultrasound?
2. Can artificial intelligent reduce the number of cases and time for doctors to master the contrast-enhanced ultrasound diagnosis of thyroid nodules?

Participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. Researchers will compare the number of cases and time for doctors with and without artificial intelligent assistance to master the contrast-enhanced ultrasound diagnosis of thyroid nodules to see if artificial intelligent reduce the number of cases and time.

Enrollment: 1,000 estimated 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

1,000 participants in 3 patient groups

Training set

Description:

Patients with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2018 and December 2020 in Sun Yat-sen Memorial Hospital Sun Yat-sen University.

Treatment:

Other: Artificial Intelligent

Internal test set

Description:

Patients with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2021 and May 2023 in Sun Yat-sen Memorial Hospital Sun Yat-sen University.

Treatment:

Other: Artificial Intelligent

External test set

Description:

Patients with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2022 and June 2023 in Houjie Hospital of Dongguan and Central People's Hospital of Zhanjiang.

Treatment:

Other: Artificial Intelligent