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Real-time Diagnosis of Diminutive Colorectal Polyps Using AI (COMET-OPTICAL)

29 de abril de 2022 actualizado por: Maastricht University Medical Center

Real Time Computer-aided Diagnosis (CADx) of Diminutive Colorectal Polyps Using Artificial Intelligence

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. Aim of this study is to investigate the real-time diagnostic performance of AI4CRP for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available CADx systems.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Despite additional training, even experienced endoscopists continue to fail meeting international thresholds set for safe implementation of treatment strategies based on optical diagnosis.

Multiple machine learning techniques - computer-aided diagnosis (CADx) systems - have been developed for applications in medical imaging within colonoscopy and can improve endoscopic classification of colorectal polyps.

Aim of this study is to explore the feasibility of the workflow using AI4CRP (a CNN based CADx system) real-time in the endoscopy suite, and to investigate the real-time diagnostic performance of AI4CRP for the diagnosis of diminutive (<5mm) colorectal polyps. Secondary, the real-time performance of commercially available CADx systems will be investigated and compared with AI4CRP performance.

Tipo de estudio

De observación

Inscripción (Anticipado)

105

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Países Bajos
    • Limburg
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Países Bajos, 5623 EJ
        • Terminado
        • Catharina Ziekenhuis Eindhoven

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patient receiving a colonoscopy because of regular care will be considered eligible for inclusion if at least one diminutive colorectal polyp is encountered during the colonoscopy. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases.

Descripción

Inclusion Criteria:

  • Age >18 years;
  • Patients with at least one colorectal polyps encountered during colonoscopy;
  • Patients referred for a colonoscopy by the Dutch bowel cancer screening program, patients undergoing a colonoscopy for endoscopic surveillance, or patients undergoing a colonoscopy because of complaints;
  • Written informed consent.

Exclusion Criteria:

  • Patients with prior history of inflammatory bowel diseases (IBD) or polyposis syndromes;
  • Patients with inadequate bowel preparations after adequate washing, suctioning, and cleaning manoeuvres have been performed by the endoscopist;
  • Patients undergoing an emergency colonoscopy;
  • Written objection in the patient file for participation in scientific research.

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Gastroenterology patients

Patient receiving a colonoscopy because of regular care will be considered eligible for inclusion if at least one diminutive colorectal polyp is encountered during the colonoscopy. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases.

Colonoscopies will be executed using Fujifilm endoscopy systems (Fujifilm® Corporation, Tokyo, Japan), using Pentax endoscopy systems (Pentax Medical®, Hamburg, Germany), and using Olympus endoscopy systems (Olympus®, Tokyo, Japan).
Dispositivo: Computer-aided diagnosis (CADx) systems
  • AI4CRP (artificial intelligence for colorectal polyps), a CNN based computer-aided diagnosis system for diagnosis of colorectal polyps (COMET-OPTICAL research group);
  • CAD EYE, a computer-aided diagnosis system for diagnosis of colorectal polyps (Fujifilm® Corporation, Tokyo, Japan).
Otros nombres:
  • AI4CRP, artificial intelligence for colorectal polyps (COMET-OPTICAL research group)
  • CAD EYE (Fujifilm® Corporation, Tokyo, Japan)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Technical feasibility of real-time use of AI4CRP.
Periodo de tiempo: 6 months
The technical feasibility of real-time use of AI4CRP in the endoscopy suite regarding a proper reception of the video output from the local endoscopy processor towards AI4CRP (in high definition quality, without any delays in time).
6 months
User interface feasibility of real-time use of AI4CRP.
Periodo de tiempo: 6 months
The user interface feasibility of real-time use of AI4CRP in the endoscopy suite regarding a correct alignment of the user interface of AI4CRP with the video output from the local endoscopy system (resizing image pixels and anonymization).
6 months
The diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Periodo de tiempo: 1 year
The real-time diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). Diagnostic accuracy defined as the percentage of correctly optically diagnosed colorectal polyps.
1 year
The sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Periodo de tiempo: 1 year
The real-time sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Periodo de tiempo: 1 year
The real-time specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Periodo de tiempo: 1 year
The real-time negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Periodo de tiempo: 1 year
The real-time positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year
The Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Periodo de tiempo: 1 year
The real-time Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The diagnostic accuracy of AI4CRP per polyp.
Periodo de tiempo: 1 year
The real-time diagnostic accuracy of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The sensitivity of AI4CRP per polyp.
Periodo de tiempo: 1 year
The real-time sensitivity of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The specificity of AI4CRP per polyp.
Periodo de tiempo: 1 year
The real-time specificity of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The negative predictive value of AI4CRP per polyp.
Periodo de tiempo: 1 year
The real-time negative predictive value of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The positive predictive value of AI4CRP per polyp.
Periodo de tiempo: 1 year
The real-time positive predictive value of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The Area Under ROC Curve (AUC) of AI4CRP per polyp.
Periodo de tiempo: 1 year
The real-time Area Under ROC Curve (AUC) of AI4CRP per polyp (comprising the combination of different imaging modalities).
1 year
The diagnostic accuracy of CAD EYE in BLI mode, per polyp.
Periodo de tiempo: 1 year
The real-time diagnostic accuracy of CAD EYE in BLI mode, per polyp.
1 year
The sensitivity of CAD EYE in BLI mode, per polyp.
Periodo de tiempo: 1 year
The real-time sensitivity of CAD EYE in BLI mode, per polyp.
1 year
The specificity of CAD EYE in BLI mode, per polyp.
Periodo de tiempo: 1 year
The real-time specificity of CAD EYE in BLI mode, per polyp.
1 year
The negative predictive value of CAD EYE in BLI mode, per polyp.
Periodo de tiempo: 1 year
The real-time negative predictive value of CAD EYE in BLI mode, per polyp.
1 year
The positive predictive value of CAD EYE in BLI mode, per polyp.
Periodo de tiempo: 1 year
The real-time positive predictive value of CAD EYE in BLI mode, per polyp.
1 year
The Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp.
Periodo de tiempo: 1 year
The real-time Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp.
1 year
The diagnostic accuracy of AI4CRP per patient.
Periodo de tiempo: 1 year
The real-time diagnostic accuracy of AI4CRP per patient (in case of multiple polyps per patient).
1 year
The diagnostic accuracy of CAD EYE per patient.
Periodo de tiempo: 1 year
The real-time diagnostic accuracy of CAD EYE per patient (in case of multiple polyps per patient).
1 year
The localization score of AI4CRP.
Periodo de tiempo: 1 year
The localization score of AI4CRP regarding the number of images in which the heatmap produced by AI4CRP pointed out the area of interest (scale: correct, incorrect, or partly correct area of interest).
1 year
The difference in diagnostic accuracy of endoscopists per polyp before and after AI.
Periodo de tiempo: 1 year
The difference in real-time diagnostic accuracy of endoscopists per polyp before and after AI.
1 year
The difference in sensitivity of endoscopists per polyp before and after AI.
Periodo de tiempo: 1 year
The difference in real-time sensitivity of endoscopists per polyp before and after AI.
1 year
The difference in specificity of endoscopists per polyp before and after AI.
Periodo de tiempo: 1 year
The difference in real-time specificity of endoscopists per polyp before and after AI.
1 year
The difference in negative predictive value of endoscopists per polyp before and after AI.
Periodo de tiempo: 1 year
The difference in real-time negative predictive value of endoscopists per polyp before and after AI.
1 year
The difference in positive predictive value of endoscopists per polyp before and after AI.
Periodo de tiempo: 1 year
The difference in real-time positive predictive value of endoscopists per polyp before and after AI.
1 year
The agreement in surveillance interval based on optical diagnosis and histopathology.
Periodo de tiempo: 1 year
The agreement in surveillance interval based on optical diagnosis of diminutive colorectal polyps and histopathology of small and large colorectal polyps, compared to the surveillance interval based on histopathology of all colorectal polyps (diminutive, small, and large).
1 year

Colaboradores e Investigadores

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

Patrocinador

Maastricht University Medical Center

Colaboradores

Catharina Ziekenhuis Eindhoven
Eindhoven University of Technology

Investigadores

  • Investigador principal: Erik Schoon, Prof Dr MD, Maastricht Universitair Medisch Centrum

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)

20 de agosto de 2021

Finalización primaria (Anticipado)

1 de septiembre de 2022

Finalización del estudio (Anticipado)

1 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

31 de marzo de 2022

Primero enviado que cumplió con los criterios de control de calidad

21 de abril de 2022

Publicado por primera vez (Actual)

27 de abril de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de mayo de 2022

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

29 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • METC2021-3036

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

A data sharing plan is not yet decided on.

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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