Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules

June 1, 2022 updated by: Luo Dingcun
To study the value of thyroid artificial intelligence diagnosis system and fine needle puncture in the diagnosis of benign and malignant thyroid nodules, so as to provide evidence-based medical evidence for the diagnosis of benign and malignant thyroid nodules by artificial intelligence.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) Age 18-75 years old, regardless of gender; (2) The nodules were observed with complete transverse and longitudinal standard sections; (3) The nodules were observed and underwent thyroid fine needle aspiration, including cytology and BRAF gene mutation detection; (4) Patients voluntarily entered the study after informed consent.

Exclusion Criteria:

  • (1) If the observed nodule is less than 2mm or more than 50mm, the artificial intelligence system cannot recognize it; (2) Uncontrolled subacute thyroiditis and hyperthyroidism; (3) Previous thyroid surgery or radiofrequency ablation of thyroid nodules; (4) History of neck trauma.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THYROID AI
Diagnostic test: THYROID AI
thyroid artificial intelligence diagnosis system and fine needle puncture in the diagnosis of benign and malignant thyroid nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THYROID AI
Time Frame: immediately after the procedure
classify thyroid nodules as Benign or Malignant
immediately after the procedure

Collaborators and Investigators

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

Sponsor

Luo Dingcun

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhejiangU20220602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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