Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules (AI)

April 17, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • SAHZJU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with thyroid nodule

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with 1827 Nodule Classification
Time Frame: up to 4 weeks
nodules with Pathology or cytopathology result
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thyroid AI-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets during the current study available for participants from the sponsor on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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