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

Recruiting

• Conditions: Microvascular Classification; Multimoda Lultasound; Thyroid Cancer
• Interventions: Diagnostic Test: ultrasound

• Registration Number: NCT06530771
• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-12
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malignant thyroid nodules	ultrasound	-
Benign thyroid nodules	ultrasound	-

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy	one week	sensitivity, specificity, accuracy
positive predictive value (PPV), and negative predictive value (NPV)	one week	Diagnostic efficacy

Trial Locations

Locations (1)

The Fifth Affiliated Hospital Sun Yat-Sen University; 🇨🇳 Zhuhai, Guangdong, China