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

Primary Purpose

Thyroid Nodule

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
THYROID AI
Sponsored by
Luo Dingcun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Nodule

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    THYROID AI

    Arm Description

    Outcomes

    Primary Outcome Measures

    THYROID AI
    classify thyroid nodules as Benign or Malignant

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2022
    Last Updated
    June 1, 2022
    Sponsor
    Luo Dingcun
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05407506
    Brief Title
    Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules
    Official Title
    Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Luo Dingcun

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Nodule

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    THYROID AI
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    THYROID AI
    Intervention Description
    thyroid artificial intelligence diagnosis system and fine needle puncture in the diagnosis of benign and malignant thyroid nodules
    Primary Outcome Measure Information:
    Title
    THYROID AI
    Description
    classify thyroid nodules as Benign or Malignant
    Time Frame
    immediately after the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dingcun Luo
    Phone
    +86057156005600
    Email
    wlsydxjk@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dingcun Luo
    Organizational Affiliation
    First People's Hospital of Hangzhou
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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