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NCT Number: NCT07488325

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Histopathology or cytopathology.

Other

This is a observation stufy.

Primary outcomes

  1. Pathological diagnosis.

    Time frame: One month after the surgery.

    WHO guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingliang Ruan, Ph.D.

CONTACT

[email protected]

+8613694202230

Xinmin Xiao, B.S.

CONTACT

+8618420058253

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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