Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer

NCT06498674 | Recruiting

• 1 other identifier: AI-base PCD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the application of AI-assisted ultrasound technology in the preoperative assessment of thyroid cancer. Traditional ultrasound examination data from thyroid cancer patients will be collected, and AI systems will be utilized to detect and diagnose thyroid nodules and lymph nodes. In cases where there is disagreement between the two-dimensional ultrasound and AI system results, further confirmation will be sought through biopsy. Subsequently, pathological results will serve as the "gold standard" for comparison between the AI system and traditional ultrasound examination results, assessing their accuracy and reliability. Through this research endeavor, a more accurate and reliable method for preoperative assessment of thyroid cancer is aspired to be offered, thereby supporting clinical decision-making and paving the way for novel applications of AI in the field of medical imaging diagnosis.

Conditions

Thyroid Cancer

Keywords

Thyroid Cancer; Artificial Intelligence; Ultrasound; Preoperative Assessment

Outcome Measures

Primary Outcomes (2)

• Supplementary Pathological Examination

  For patients who have completed traditional two-dimensional color ultrasound and AI-assisted ultrasound, record whether a supplementary pathological examination was conducted.

  One day after surgery

• Change in Treatment Decision

  For patients who have completed traditional two-dimensional color ultrasound, AI-assisted ultrasound, and undergone supplementary pathological examination, record whether there was a change in the surgical approach or scope.

  One day after surgery

Secondary Outcomes (8)

• Traditional Two-Dimensional Color Ultrasound Findings

  Preoperative

• AI-Assisted Ultrasound Interpretation Results

  Preoperative

• Supplementary Pathological Examination Results

  One day Postoperative

• Postoperative Pathology Report

  One day after the postoperative pathology report is released

• Statistical Indicators

  One day after the postoperative pathology report is released

Study Arms (2)

Concordant Group

OTHER

Patients in whom the detection and diagnostic results of thyroid nodules and lymph nodes are consistent between traditional two-dimensional ultrasound and AI-assisted ultrasound.

Other: No Need for Supplementary Pathological Examination

Discordant Group

OTHER

Patients in whom the detection and diagnostic results of thyroid nodules and lymph nodes differ between traditional two-dimensional ultrasound and AI-assisted ultrasound.

Diagnostic Test: Supplementary Pathological Examination

Interventions

Supplementary Pathological Examination DIAGNOSTIC_TEST

For the same thyroid nodule, if there is discordance between the interpretations of AI-assisted ultrasound and traditional two-dimensional ultrasound, supplementary fine needle aspiration biopsy or intraoperative biopsy will be performed to clarify the nature of the nodule.

Discordant Group

No Need for Supplementary Pathological Examination OTHER

For the same thyroid nodule, if there is discordance between the interpretations of AI-assisted ultrasound and traditional two-dimensional ultrasound, there is no need for supplementary fine needle aspiration biopsy or intraoperative biopsy.

Concordant Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with preoperative pathological confirmation of thyroid malignant tumors undergoing surgical treatment.
• Patients with benign thyroid tumors, such as thyroid adenomas causing compressive symptoms, undergoing surgical treatment.
• Patients with complete and high-quality traditional two-dimensional color ultrasound images.
• Complete postoperative pathology reports.
• Willingness to participate in this clinical trial and signing of informed consent.

You may not qualify if:

• Patients with a history of neck surgery or radiotherapy.
• Patients with a history of malignant tumors in other parts of the body.
• Patients with thyroid dysfunction.
• Incomplete or poor-quality traditional two-dimensional color ultrasound images.
• Incomplete postoperative pathology reports.
• Refusal to participate in this clinical trial.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Bo Wang Professor

CONTACT

13959123550; wangbo@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor Affiliation: Fujian Medical University Collaborators:

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)