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Aplicación clínica de la tecnología de ultrasonido asistida por IA en la evaluación preoperatoria del cáncer de tiroides

5 de agosto de 2026 actualizado por: Bo Wang,MD, Fujian Medical University
Este estudio tiene como objetivo explorar la aplicación de la tecnología de ultrasonido asistida por IA en la evaluación preoperatoria del cáncer de tiroides. Se recopilarán datos de exámenes de ultrasonido tradicionales de pacientes con cáncer de tiroides y se utilizarán sistemas de inteligencia artificial para detectar y diagnosticar nódulos tiroideos y ganglios linfáticos. En los casos en los que haya desacuerdo entre los resultados de la ecografía bidimensional y los del sistema de IA, se buscará una confirmación adicional mediante una biopsia. Posteriormente, los resultados patológicos servirán como "estándar de oro" para comparar el sistema de IA y los resultados de los exámenes de ultrasonido tradicionales, evaluando su precisión y confiabilidad. A través de este esfuerzo de investigación, se aspira a ofrecer un método más preciso y confiable para la evaluación preoperatoria del cáncer de tiroides, apoyando así la toma de decisiones clínicas y allanando el camino para nuevas aplicaciones de la IA en el campo del diagnóstico por imágenes médicas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Este estudio tiene como objetivo investigar la aplicación de la tecnología de ultrasonido asistida por IA en la evaluación preoperatoria del cáncer de tiroides. Los datos de los exámenes de ultrasonido tradicionales de pacientes con cáncer de tiroides, incluidas imágenes de ultrasonido bidimensionales, imágenes de flujo Doppler en color y características detalladas de los nódulos tiroideos y ganglios linfáticos, como número, tamaño, morfología, ecogenicidad, márgenes, calcificaciones y relación de aspecto, ser recogido. Antes de la cirugía, se realizará una reevaluación utilizando tecnología de ultrasonido asistida por IA, y se registrarán los resultados de detección y diagnóstico de nódulos tiroideos y ganglios linfáticos mediante el sistema de IA. En los casos en que exista discrepancia entre los resultados de la ecografía bidimensional y el sistema de IA, se realizará una biopsia por aspiración con aguja fina o una biopsia intraoperatoria para una mayor confirmación de su naturaleza. Después de la cirugía, los resultados patológicos de cada nódulo servirán como "estándar de oro" para el análisis comparativo entre el sistema de inteligencia artificial y los exámenes de ultrasonido bidimensionales tradicionales. Se analizará la precisión del sistema de IA en la detección y localización de nódulos y se calculará su sensibilidad, especificidad y precisión para evaluar su eficacia diagnóstica y confiabilidad en la evaluación preoperatoria del cáncer de tiroides. A través de esta investigación, se pretende proporcionar un método de diagnóstico complementario más preciso y confiable para la evaluación preoperatoria del cáncer de tiroides para ayudar en la toma de decisiones clínicas. Además, se explorarán nuevas vías y direcciones para la aplicación de la IA en el campo del diagnóstico por imágenes médicas.

Tipo de estudio

Intervencionista

Inscripción (Actual)

515

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Pacientes con confirmación patológica preoperatoria de tumores malignos de tiroides sometidos a tratamiento quirúrgico.
  • Pacientes con tumores benignos de tiroides, como adenomas de tiroides que causan síntomas compresivos, sometidos a tratamiento quirúrgico.
  • Pacientes con imágenes ecográficas bidimensionales en color tradicionales completas y de alta calidad.
  • Informes completos de patología postoperatoria.
  • Voluntad de participar en este ensayo clínico y firma de consentimiento informado.

Criterio de exclusión:

  • Pacientes con antecedentes de cirugía de cuello o radioterapia.
  • Pacientes con antecedentes de tumores malignos en otras partes del cuerpo.
  • Pacientes con disfunción tiroidea.
  • Imágenes ecográficas bidimensionales en color tradicionales incompletas o de mala calidad.
  • Informes de patología postoperatoria incompletos.
  • Negativa a participar en este ensayo clínico.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Prueba de diagnóstico: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fujian Medical University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2024

Finalización primaria (Actual)

28 de septiembre de 2025

Finalización del estudio (Actual)

15 de octubre de 2025

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2024

Primero enviado que cumplió con los criterios de control de calidad

11 de julio de 2024

Publicado por primera vez (Actual)

12 de julio de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AI-base PCD

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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