Actively Recruiting
Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-04-01
396
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are working to develop a multimodal deep learning model that combines ultrasound images and cytology whole-slide images to better predict the risk of malignancy in Bethesda III thyroid nodules. This study focuses on patients who have had fine-needle aspiration biopsies of thyroid nodules categorized as Bethesda III, with the goal of improving diagnostic accuracy for these uncertain cases. The study involves building and testing three types of models: one based on ultrasound images, one on cytology images, and a fusion model that integrates both image types. The patients included in this research underwent conventional ultrasound exams and fine-needle aspiration between 2016 and 2024. The final diagnosis is confirmed either by postoperative histopathology or testing for the BRAFV600E mutation. Participants' ultrasound and cytology images will be analyzed, and their surgical pathology results will be used as the reference standard. The main outcome measured is the pathological diagnosis confirmed one month after surgery. The researchers will assess how well the models predict malignancy using statistical methods and evaluate their usefulness in clinical decision-making. The study is observational and does not involve experimental treatments.
CONDITIONS
Brief Title
Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda III.
- Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions.
- Availability of at least one ultrasound image acquired prior to surgery.
You will not qualify if you...
- Patients without confirmation by surgical pathology.
- Patients without any available or usable ultrasound images.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks before surgery
Participants undergo ultrasound imaging and fine-needle aspiration to collect cytological samples for assessment of thyroid nodules.
1 to 2 visits depending on imaging and biopsy scheduling
Duration - Day of surgery
Participants who have confirmed thyroid nodules undergo thyroid surgery to obtain tissue for histopathological diagnosis.
1 visit (surgery day)
Duration - 1 month after surgery
Participants are followed after surgery to confirm pathological diagnosis and assess outcomes based on histopathology or BRAFV600E mutation results.
1 follow-up visit about one month after surgery
Trial Site Locations
Total: 1 location
1
No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital
Guangzhou, Guangzhou, China, 510288
Actively Recruiting
Research Team
J
Jingliang Ruan, Ph.D.
X
Xinmin Xiao, B.S.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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