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

Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Guide the Fine-Needle Aspiration Management of Thyroid Lesions: Focus on the Innovative Microvascular Classification

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer; Multimoda Lultasound; Microvascular Classification
• Intervention / Treatment: Diagnostic test: ultrasound

• Study Type: Observational
• Enrollment (Estimated): 720

Contacts and Locations

• Study Contact: Name: Xin Wen; Phone Number: 15913232456; Email: wenxin7@mail.sysu.edu.cn
• Study Contact Backup: Name: Jiamin Chen; Phone Number: 13546875774; Email: chenjm286@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital Sun Yat-Sen University
      • Contact: TianXin Lin, MD; Phone Number: +8613724008338

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Population data for this prospective single-center cohort study were gathered at the Fifth Affiliated Hospital of Sun Yat-sen University.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Malignant thyroid nodules	Diagnostic test: ultrasound; Conventional US, SWE, and AP of thyroid nodules were conducted successively with a Supersonic Aixplorer system (SuperSonic Imagine, Aix-en-Provence, France) using a 5-14 MHz linear transducer.
Benign thyroid nodules	Diagnostic test: ultrasound; Conventional US, SWE, and AP of thyroid nodules were conducted successively with a Supersonic Aixplorer system (SuperSonic Imagine, Aix-en-Provence, France) using a 5-14 MHz linear transducer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic efficacy	the area under the receiver operating characteristic (ROC) curve (AUC)	one week
Diagnostic efficacy	sensitivity, specificity, accuracy	one week
positive predictive value (PPV), and negative predictive value (NPV)	Diagnostic efficacy	one week

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: ZDWY.CSK.008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No