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

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Diagnostic Test: THYROID AI

• Registration Number: NCT05407506
• Lead Sponsor: Luo Dingcun

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
THYROID AI	THYROID AI	-

Primary Outcome Measures

Name	Time	Method
THYROID AI	immediately after the procedure	classify thyroid nodules as Benign or Malignant