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Recruiting NCT07488325

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

Observational Thyroid Nodule

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Histopathology or cytopathology..
Who it may be relevant to
Registry conditions: Thyroid Nodule. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Histopathology or cytopathology.
    This is a observation stufy.

Primary outcome measures

  • Pathological diagnosis. [Time frame: One month after the surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Mem — Guangzhou

Identifiers

NCT: NCT07488325 · SYSEC-AF-SW09-06.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗