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Clinical Trials/NCT07496684
NCT07496684CompletedNot Applicable

Application and Evaluation of Vision-LSTM Model in Diagnostic Ultrasound Imaging of TI-RADS Class 4b Thyroid Nodules

Ma Zhe1 site in 1 country401 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
401
Locations
1
Primary Endpoint
Accuracy of diagnostic models

Study Overview

Brief Summary

The aim of this study was to evaluate the performance of artificial intelligence (AI) technology in the diagnosis of thyroid nodules, specifically in the field of ultrasound image analysis. It focuses on the accuracy and clinical feasibility of the AI system based on the Vision-LSTM model in the diagnosis of TI-RADS category 4b thyroid nodules.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
20 Years to 78 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •(1) Patients with thyroid nodules visible on ultrasound who underwent biopsy and/or surgical resection. (2) Diagnosed as TI-RADS category 4b on the basis of preoperative ultrasound images by two sonographers with more than 5 years of experience in thyroid ultrasound diagnosis. (3) All nodules underwent puncture biopsy or surgery to obtain pathologic results.

Exclusion Criteria

  • •(1)The quality of the patient's ultrasound images was poor. (2) The patient has incomplete clinical and imaging data. (3) The patient has had thyroid surgery or other treatment.

Arms & Interventions

maligant

patients with maligant thyroid masses who underwent biopsy and/or surgical resection.

benign

patients with benign thyroid masses who underwent biopsy and/or surgical resection.

Outcomes

Primary Outcomes

Accuracy of diagnostic models

Time Frame: Immediately evaluated after the diagnostic model was built

The study collected ultrasound imaging data from 401 cases of TI-RADS 4b thyroid nodules at our hospital and used this data to train and validate the Vision-LSTM model. The diagnostic results of the AI model were compared with those of junior and senior clinicians to evaluate its performance in terms of diagnostic accuracy and stability; model performance was quantified using metrics such as the area under the curve (AUC) and the precision-recall curve (PR curve).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ma Zhe
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ma Zhe

Chief Physician

Qianfoshan Hospital

Study Sites (1)

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