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

NCT ID: NCT06530771

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-30

Brief Summary

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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

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Conditions

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Multimoda Lultasound Thyroid Cancer Microvascular Classification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Malignant thyroid nodules

ultrasound

Intervention Type 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

ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Wen

Role: CONTACT

Phone: 15913232456

Email: [email protected]

Jiamin Chen

Role: CONTACT

Phone: 13546875774

Email: [email protected]

Facility Contacts

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TianXin Lin, MD

Role: primary

Other Identifiers

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ZDWY.CSK.008

Identifier Type: -

Identifier Source: org_study_id