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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Concordant GroupOther 1 intervention
Group B: Discordant GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
One day after surgery
2

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.

Time frame
One day after surgery

Secondary outcomes

1

Traditional Two-Dimensional Color Ultrasound Findings

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.

Time frame
Preoperative
2

AI-Assisted Ultrasound Interpretation Results

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.

Time frame
Preoperative
3

Supplementary Pathological Examination Results

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

Time frame
One day Postoperative
4

Postoperative Pathology Report

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

Time frame
One day after the postoperative pathology report is released

Other outcomes

Sponsors and contacts

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