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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06530771
Enrollment
720
Registered
2024-07-31
Start date
2022-07-01
Completion date
2024-12-30
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular Classification, Multimoda Lultasound, Thyroid Cancer

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

Interventions

DIAGNOSTIC_TESTultrasound

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.

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic efficacyone weekthe area under the receiver operating characteristic (ROC) curve (AUC)
positive predictive value (PPV), and negative predictive value (NPV)one weekDiagnostic efficacy

Countries

China

Contacts

Primary ContactXin Wen
wenxin7@mail.sysu.edu.cn15913232456
Backup ContactJiamin Chen
chenjm286@mail2.sysu.edu.cn13546875774

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026