NCT07488325

Multimodal Assessment of Malignancy in Atypia of Undetermined Significance in Thyroid Nodules Using Ultrasound and Cytology Whole-Slide Images

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 396 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The prospective study aim to develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules.

Detailed description

Objectives: To develop a multimodal deep learning model that integrates ultrasound images and cytological whole-slide images for more accurate malignant risk prediction of Bethesda III thyroid nodules. Materials and Methods: A ultrasound model, a cytology model, and a fusion model were constructed in this single-center retrospective diagnostic accuracy test. Consecutive patients with Bethesda III thyroid nodules who underwent conventional US examination and fine-needle aspirations were included between January 2016 and December 2024 in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The reference standard was postoperative histopathology or BRAFV600E mutation. Receiver operating characteristic curve analysis was used to evaluate the diagnostic performance, and decision curve analysis was used to assess the clinical utility.

Conditions

• Thyroid Nodule

Interventions

Type	Name	Description
OTHER	Histopathology or cytopathology.	This is a observation stufy.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-30
• Completion: 2026-07-15
• First posted: 2026-03-23
• Last updated: 2026-04-01

Locations

1 site across 1 country: China