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Clinical Trials/NCT06530771
NCT06530771
Recruiting
Not Applicable

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

Fifth Affiliated Hospital, Sun Yat-Sen University1 site in 1 country720 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multimoda Lultasound
Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Enrollment
720
Locations
1
Primary Endpoint
Diagnostic efficacy
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Diagnostic efficacy

Time Frame: one week

sensitivity, specificity, accuracy

positive predictive value (PPV), and negative predictive value (NPV)

Time Frame: one week

Diagnostic efficacy

Study Sites (1)

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