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Aplicação clínica da tecnologia de ultrassom assistida por IA na avaliação pré-operatória do câncer de tireoide

5 de agosto de 2026 atualizado por: Bo Wang,MD, Fujian Medical University
Este estudo tem como objetivo explorar a aplicação da tecnologia de ultrassom assistida por IA na avaliação pré-operatória do câncer de tireoide. Serão coletados dados de exames de ultrassom tradicionais de pacientes com câncer de tireoide e sistemas de IA serão utilizados para detectar e diagnosticar nódulos e gânglios linfáticos da tireoide. Nos casos em que houver discordância entre os resultados do ultrassom bidimensional e do sistema de IA, será solicitada confirmação adicional por meio de biópsia. Posteriormente, os resultados patológicos servirão como “padrão ouro” para comparação entre o sistema de IA e os resultados dos exames de ultrassom tradicionais, avaliando sua precisão e confiabilidade. Através deste esforço de pesquisa, pretende-se oferecer um método mais preciso e confiável para avaliação pré-operatória do câncer de tireoide, apoiando assim a tomada de decisões clínicas e abrindo caminho para novas aplicações de IA no campo do diagnóstico por imagens médicas.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Este estudo tem como objetivo investigar a aplicação da tecnologia de ultrassom assistida por IA na avaliação pré-operatória do câncer de tireoide. Os dados tradicionais de exames de ultrassom de pacientes com câncer de tireoide, incluindo imagens de ultrassom bidimensionais, imagens de fluxo Doppler colorido e características detalhadas de nódulos e linfonodos da tireoide, como número, tamanho, morfologia, ecogenicidade, margens, calcificações e proporção de aspecto, serão ser coletado. Antes da cirurgia, uma reavaliação será realizada usando tecnologia de ultrassom assistida por IA, e os resultados de detecção e diagnóstico de nódulos tireoidianos e linfonodos pelo sistema de IA serão registrados. Nos casos em que houver discrepância entre os resultados da ultrassonografia bidimensional e do sistema de IA, será realizada biópsia aspirativa com agulha fina ou biópsia intraoperatória para maior confirmação de sua natureza. Pós-cirurgia, os resultados patológicos de cada nódulo servirão como “padrão ouro” para análise comparativa entre o sistema de IA e os exames tradicionais de ultrassom bidimensional. A precisão do sistema de IA na detecção e localização de nódulos será analisada, e sua sensibilidade, especificidade e precisão serão calculadas para avaliar sua eficácia diagnóstica e confiabilidade na avaliação pré-operatória do câncer de tireoide. Através desta pesquisa, pretende-se fornecer um método diagnóstico adjuvante mais preciso e confiável para a avaliação pré-operatória do câncer de tireoide para auxiliar na tomada de decisões clínicas. Além disso, serão explorados novos caminhos e direções para a aplicação da IA ​​no campo do diagnóstico por imagens médicas.

Tipo de estudo

Intervencional

Inscrição (Real)

515

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Pacientes com confirmação anatomopatológica pré-operatória de tumores malignos da tireoide submetidos a tratamento cirúrgico.
  • Pacientes com tumores benignos da tireoide, como adenomas de tireoide que causam sintomas compressivos, submetidos a tratamento cirúrgico.
  • Pacientes com imagens de ultrassom coloridas bidimensionais tradicionais completas e de alta qualidade.
  • Relatórios completos de patologia pós-operatória.
  • Disponibilidade para participar deste ensaio clínico e assinatura do consentimento informado.

Critério de exclusão:

  • Pacientes com histórico de cirurgia no pescoço ou radioterapia.
  • Pacientes com histórico de tumores malignos em outras partes do corpo.
  • Pacientes com disfunção tireoidiana.
  • Imagens de ultrassom coloridas bidimensionais tradicionais incompletas ou de baixa qualidade.
  • Relatórios patológicos pós-operatórios incompletos.
  • Recusa em participar deste ensaio clínico.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: AI-Assisted Preoperative Review
Participants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output. The AI system does not assess cervical lymph nodes. All supplementary examinations and final diagnostic and surgical decisions are made by clinicians.
Teste de diagnostico: Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review
After standard preoperative ultrasonography, the same participant underwent a standardized AI-assisted repeat examination. The locked system identified and classified thyroid nodules and provided malignancy-score information for surgeon-led review. It did not assess cervical lymph nodes and was not retrained or recalibrated during the study. Additional fine-needle aspiration, intraoperative pathologic examination, and surgical management were determined by clinicians using the complete clinical assessment.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
Prazo: From completion of the AI-assisted repeat examination through completion of surgery
Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery. Each participant is counted once regardless of the number of examinations. The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
From completion of the AI-assisted repeat examination through completion of surgery
Proportion of Participants With a Change in Planned Surgical Management
Prazo: From completion of the AI-assisted review through surgery
Number and proportion of enrolled participants with at least one documented change in the surgeon-led planned surgical approach or extent after conventional ultrasonography, AI-assisted review, and any supplementary pathological examination, when performed. Changes may involve thyroid resection or cervical lymph-node management. Each participant is counted once regardless of the number of changes. The AI system provided thyroid-nodule information only and did not assess cervical lymph nodes.
From completion of the AI-assisted review through surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules
Prazo: During standard preoperative ultrasonography, before the AI-assisted repeat examination
Number and percentage of evaluated thyroid nodules in each clinician-assigned C-TIRADS category during conventional ultrasonography. Nodule size, composition, echogenicity, margins, calcifications, and clinician-assessed cervical lymph-node findings were recorded as descriptive covariates and were not treated as separate outcome measures.
During standard preoperative ultrasonography, before the AI-assisted repeat examination
Proportion of Evaluated Thyroid Nodules Classified as AI-Positive
Prazo: During the preoperative AI-assisted repeat examination, before surgery
Number and percentage of evaluated thyroid nodules with a locked AI malignancy score >0.5. The AI system evaluated thyroid nodules only and did not assess cervical lymph nodes.
During the preoperative AI-assisted repeat examination, before surgery
Results of Supplementary Cytologic or Pathologic Examinations
Prazo: From supplementary sampling to availability of the corresponding result, before or during surgery
Among participants who underwent at least one additional cytologic or pathologic examination, record the cytologic or histopathologic result for each sampled thyroid nodule or cervical lymph node. Results are summarized at the examination level as nonmalignant, indeterminate, malignant, or metastatic, as applicable.
From supplementary sampling to availability of the corresponding result, before or during surgery
Final Histopathological Diagnosis of Resected Thyroid Nodules
Prazo: From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
For each resected thyroid nodule linked unambiguously to the evaluated lesion, record the final diagnosis as benign, malignant, follicular tumor of uncertain malignant potential (FT-UMP), well-differentiated tumor of uncertain malignant potential (WDT-UMP), non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), or another borderline diagnosis.
From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Sensitivity of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Using definitive postoperative histopathology as the reference standard, sensitivity is TP/(TP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage. These lesion-level exclusions do not alter the 515-participant workflow cohort.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level False-Negative Rate of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
For each method, the false-negative rate is FN/(TP + FN), expressed as a percentage, among definitively malignant thyroid nodules. AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Positive Predictive Value of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
For each method, positive predictive value is TP/(TP + FP), expressed as a percentage, among thyroid nodules classified as positive. AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Youden Index of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
For each method, the Youden index is sensitivity + specificity - 1 using fixed binary thresholds. AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Distribution of Cervical Lymph-Node Metastasis Status Among Pathologically Examined Nodes
Prazo: From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
Among cervical lymph nodes actually removed or sampled and pathologically examined, record the number and percentage with and without metastasis. No pathologic reference diagnosis is assigned to unsampled lymph nodes.
From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Specificity of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Using definitive postoperative histopathology as the reference standard, specificity is TN/(TN + FP), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Negative Predictive Value of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Using definitive postoperative histopathology as the reference standard, negative predictive value is TN/(TN + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Accuracy of AI and C-TIRADS
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Using definitive postoperative histopathology as the reference standard, accuracy is (TP + TN)/(TP + TN + FP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Area Under the ROC Curve for the Continuous AI Malignancy Score
Prazo: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Using definitive postoperative histopathology as the reference standard, calculate the area under the receiver operating characteristic curve for the continuous locked AI malignancy score. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage. No AUC is calculated for the single-threshold C-TIRADS classification.
From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fujian Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2024

Conclusão Primária (Real)

28 de setembro de 2025

Conclusão do estudo (Real)

15 de outubro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

9 de junho de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de julho de 2024

Primeira postagem (Real)

12 de julho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AI-base PCD

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data are not planned for external sharing because the dataset contains detailed clinical records and ultrasound images that may remain re-identifiable, and the available study records do not document participant consent specifically permitting external IPD sharing or institutional authorization for such sharing. Aggregate, non-identifiable results will be reported in publications.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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