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

NCT06530771 | Unknown

• 1 other identifier: ZDWY.CSK.008
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

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

Conditions

Multimoda Lultasound; Thyroid Cancer; Microvascular Classification

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Malignant thyroid nodules

Diagnostic Test: ultrasound

Benign thyroid nodules

Diagnostic Test: ultrasound

Interventions

ultrasound DIAGNOSTIC_TEST

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; Malignant thyroid nodules

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Xin Wen

CONTACT

15913232456; wenxin7@mail.sysu.edu.cn

Jiamin Chen

CONTACT

13546875774; chenjm286@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: July 31, 2024
• Study Start: July 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2023-12

Locations

CN (1)