Artificial Intelligent Accelerates the Learning Curve for Mastering Contrast-enhanced Ultrasound of Thyroid Nodules

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05982821
Collaborator
(none)
1,000
1
35.9
27.8

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about the learning curve for mastering the thyroid imaging reporting and data system of contrast-enhanced ultrasound with the assistance of artificial intelligence in patients with thyroid nodules. The main questions it aims to answer are:

  1. Can we develop a artificial intelligent software to assist doctors in the diagnosis of thyroid nodules using contrast-enhanced ultrasound?

  2. Can artificial intelligent reduce the number of cases and time for doctors to master the contrast-enhanced ultrasound diagnosis of thyroid nodules?

Participants will be asked to undergo contrast-enhanced ultrasound examination and ultrasound-guided fine-needle aspiration of thyroid nodules. Researchers will compare the number of cases and time for doctors with and without artificial intelligent assistance to master the contrast-enhanced ultrasound diagnosis of thyroid nodules to see if artificial intelligent reduce the number of cases and time.

Condition or Disease Intervention/Treatment Phase
  • Other: Artificial Intelligent

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Artificial Intelligent Accelerates the Learning Curve for Mastering Thyroid Imaging Reporting and Data System of Contrast-enhanced Ultrasound
Anticipated Study Start Date :
Jan 3, 2024
Anticipated Primary Completion Date :
Jul 30, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Training set

Patients with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2018 and December 2020 in Sun Yat-sen Memorial Hospital Sun Yat-sen University.

Other: Artificial Intelligent
Artificial intelligence assisted radiologists to extract ultrasound features of thyroid nodules.

Internal test set

Patients with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2021 and May 2023 in Sun Yat-sen Memorial Hospital Sun Yat-sen University.

Other: Artificial Intelligent
Artificial intelligence assisted radiologists to extract ultrasound features of thyroid nodules.

External test set

Patients with thyroid nodules underwent contrast-enhanced ultrasound and ultrasound-guided fine-needle aspiration during January 2022 and June 2023 in Houjie Hospital of Dongguan and Central People's Hospital of Zhanjiang.

Other: Artificial Intelligent
Artificial intelligence assisted radiologists to extract ultrasound features of thyroid nodules.

Outcome Measures

Primary Outcome Measures

  1. Area under curve. [At the end of the first (M1), third (M3), and sixth (M6) months of the trainees' rotation.]

    Receiver operating characteristic curve analysis.

  2. The number of cases [At the end of the first (M1), third (M3), and sixth (M6) months of the trainees' rotation.]

    The faculty responsible for the training program assessed the skills of each resident.

  3. The cases time. [At the end of the first (M1), third (M3), and sixth (M6) months of the trainees' rotation.]

    The faculty responsible for the training program assessed the skills of each resident.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients with thyroid nodules with a solid component ≥5 mm confirmed by conventional ultrasound;

  • Patients who underwent conventional ultrasound, contrast-enhanced ultrasound, and fine-needle aspiration biopsy;

  • Patients with a final benign or malignant pathological results.

Exclusion Criteria:
  • Patients with cytopathology of Bethesda I, III, or IV and without final benign or malignant pathology;

  • Patients with a history of thyroid ablation or surgery;

  • Patients with low-quality ultrasound images.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510289

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jingliang Ruan, PhD, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05982821
Other Study ID Numbers:
  • SYSKY-2023-702-01
First Posted:
Aug 9, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2023