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NCT05407506 Clinical Trial

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

Thyroid Nodule Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05407506
Other study ID # ZhejiangU20220602
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2022
Est. completion date June 2024

Study information
Verified date June 2022
Source Zhejiang University
Contact Dingcun Luo
Phone +86057156005600
Email wlsydxjk@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• THYROID AI
thyroid artificial intelligence diagnosis system and fine needle puncture in the diagnosis of benign and malignant thyroid nodules

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Luo Dingcun

Outcome
Type Measure Description Time frame Safety issue
Primary THYROID AI classify thyroid nodules as Benign or Malignant immediately after the procedure
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