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NCT Number: NCT06498674

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

Bo Wang Professor

CONTACT

[email protected]

+13959123550

About this study

This study aims to investigate the application of AI-assisted ultrasound technology in the preoperative assessment of thyroid cancer. Traditional ultrasound examination data from patients with thyroid cancer, including two-dimensional ultrasound images, color Doppler flow images, and detailed characteristics of thyroid nodules and lymph nodes such as number, size, morphology, echogenicity, margins, calcifications, and aspect ratio, will be collected. Prior to surgery, a reassessment will be conducted using AI-assisted ultrasound technology, and the detection and diagnostic results of thyroid nodules and lymph nodes by the AI system will be recorded. In cases where there is discrepancy between the results of two-dimensional ultrasound and the AI system, fine needle aspiration biopsy or intraoperative biopsy will be performed for further confirmation of their nature. Post-surgery, the pathological results of each nodule will serve as the "gold standard" for comparative analysis between the AI system and traditional two-dimensional ultrasound examinations. The accuracy of the AI system in detecting and localizing nodules will be analyzed, and its sensitivity, specificity, and accuracy will be calculated to evaluate its diagnostic efficacy and reliability in the preoperative assessment of thyroid cancer. Through this research, a more accurate and reliable adjunctive diagnostic method for the preoperative assessment of thyroid cancer is aimed to be provided to assist clinical decision-making. Additionally, new avenues and directions for the application of AI in the field of medical imaging diagnosis will be explored.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Supplementary Pathological Examination

    Time frame: One day after surgery

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

  2. Change in Treatment Decision

    Time frame: One day after surgery

    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.

Secondary outcomes

  1. Traditional Two-Dimensional Color Ultrasound Findings

    Time frame: Preoperative

    Record ultrasound image features such as number, size, morphology, echogenicity, margins, calcifications, and TI-RADS score of thyroid nodules and lymph nodes under traditional two-dimensional color ultrasound.

  2. AI-Assisted Ultrasound Interpretation Results

    Time frame: Preoperative

    Record ultrasound image features such as number, size, morphology, echogenicity, margins, calcifications, and TI-RADS score of thyroid nodules and lymph nodes under AI-assisted ultrasound.

  3. Supplementary Pathological Examination Results

    Time frame: One day Postoperative

    For patients who underwent supplementary pathological examination, record the results of their pathological examination.

  4. Postoperative Pathology Report

    Time frame: One day after the postoperative pathology report is released

    Record the presence of thyroid lesions and lymph node metastasis in the postoperative pathology report.

  5. Statistical Indicators

    Time frame: One day after the postoperative pathology report is released

    Using pathological evidence as the gold standard, construct contingency tables for both preoperative traditional two-dimensional color ultrasound and AI-assisted ultrasound, calculate sensitivity, specificity

  6. Statistical Indicator missed diagnosis rate.

    Time frame: One day after the postoperative pathology report is released

    Using pathological evidence as the gold standard, construct contingency tables for both preoperative traditional two-dimensional color ultrasound and AI-assisted ultrasound, missed diagnosis rate.

  7. Statistical Indicator positive predictive value

    Time frame: One day after the postoperative pathology report is released

    Using pathological evidence as the gold standard positive predictive value

  8. Statistical Indicator Youden index

    Time frame: One day after the postoperative pathology report is released

    Using pathological evidence as the gold standard Youden index.

Study contacts

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

Bo Wang Professor

CONTACT

[email protected]

13959123550

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Sep 26, 2024

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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