Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Evaluate the Malignancy Risk Value of Thyroid Nodules

Fifth Affiliated Hospital, Sun Yat-Sen University

Status: Enrolling

Conditions: Multimoda Lultasound; Thyroid Cancer; Microvascular Classification

Treatments: Diagnostic Test: ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06530771

ZDWY.CSK.008

Details and patient eligibility

About

The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. The main questions it aims to answer are:

Can an innovative ultra-microvascular classification system based on Angio Planewave Ultrasensitive Imaging distinguish between benign and malignant thyroid nodules? How about the performance of multimodal ultrasound model to Guide the Fine-Needle Aspiration Management of Thyroid Lesions?

Participants will:

Undergo grayscale ultrasound, SWE, and Angio Planewave Ultrasensitive Imaging multimodal thyroid ultrasound examination within one week before surgery Undergo surgery and obtain the postoperative pathological diagnosis

Enrollment: 720 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age more than 18 years;
2. Voluntarily signed informed consent;
3. Have 1 or more thyroid nodules detectable by ultrasound;
4. participant underwent surgical procedure to confirm the pathologic results

Exclusion criteria

1. Nodules are accompanied by large calcifications followed by acoustic shadows
2. History of previous neck surgery or cancer, thyroid medications, radiation or surgical treatment;
3. Poor quality of retained images or non-standard operations (such as intermittent scanning and improper probe compression), and incomplete pathological results.

Trial design

720 participants in 2 patient groups

Malignant thyroid nodules

Treatment:

Diagnostic Test: ultrasound

Benign thyroid nodules

Treatment:

Diagnostic Test: ultrasound