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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07488325

Enrollment

396

Registered

2026-03-23

Start date

2026-03-01

Completion date

2026-07-15

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule, Atypia of Undetermined Significance, Multimodal Deep Learning, Ultrasound, Cytology Whole-Slide Image

Brief 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.

Interventions

OTHERHistopathology or cytopathology.

This is a observation stufy.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* (a) Patients who underwent fine-needle aspiration of thyroid nodules and received a cytological diagnosis of Bethesda Ⅲ. * (b) Patients who subsequently underwent thyroid surgery with a definitive histopathological diagnosis of benign or malignant lesions,. * (c) Availability of at least one ultrasound image acquired prior to surgery.

Exclusion criteria

* (a) Patients without confirmation by surgical pathology,. * (b) Patients without any available or usable ultrasound images.

Design outcomes

Primary

Measure	Time frame	Description
Pathological diagnosis.	One month after the surgery.	WHO guidelines.

Countries

China

Contacts

CONTACTJingliang Ruan, Ph.D.

ruanjl3@mail.sysu.edu.cn+8613694202230

CONTACTXinmin Xiao, B.S.

+8618420058253

PRINCIPAL_INVESTIGATORJingliang Ruan, Ph.D.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026