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NCT05816629 Clinical Trial

Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules

Thyroid Nodule Clinical Trial

— AI  

Official title:
Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules: an International Multi-center Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05816629
Other study ID # Thyroid AI-2023
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 20, 2023
Est. completion date December 31, 2025

Study information
Verified date January 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The cases that fulfill the inclusion criteria will be enrolled with written informed consent. Images and videos will be collected in accordance with the procedure, uploaded to Ruiying Cloud, followed up, and registered with basic case information, such as thyroid function, FNA/surgical pathology results, etc.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 2000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18~80 years old; - Thyroid nodules (ACR-TI RADS category 3-5,category 3 nodules =1cm submitted for FNA) or clustered micro-calcifications; - The patients schedule to perform FNA/surgery within 1 month; - Without any history of invasive procedure of thyroid before (such as FNA,CNB, ablation, radiation, or surgery). Exclusion Criteria: - Incomplete data; - Contraindications of CEUS

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Multiparameter ultrasound based-AI
Multiparameter ultrasound based-AI for the diagnosis of thyroid nodules

Locations
Country Name City State
China SAHZJU Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with 1827 Nodule Classification nodules with Pathology or cytopathology result up to 4 weeks
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