Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules
Sponsor
Luo Dingcun (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05407506
Collaborator
(none)
1,000
1
24
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules
Anticipated Study Start Date
:
Jun 1, 2022
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Jun 1, 2024
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- THYROID AI [immediately after the procedure]
classify thyroid nodules as Benign or Malignant
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Luo Dingcun
Investigators
- Principal Investigator: Dingcun Luo, First People's Hospital of Hangzhou
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Luo Dingcun,
vice president of hospital,
Zhejiang University
ClinicalTrials.gov Identifier:
NCT05407506
Other Study ID Numbers:
- ZhejiangU20220602
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: