Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study (INSIGHT)
26 de agosto de 2026 actualizado por: Alexandre Vontobel Padoin
Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study (INSIGHT Study)
This prospective randomized controlled study aims to evaluate the diagnostic accuracy of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for detection and optical characterization of colorectal lesions during colonoscopy.
The performance of VIST and SFI will be compared with high-definition white light endoscopy (WLE), using histopathology as the reference standard and established endoscopic classifications (Paris, Kudo, and JNET).
The study will also assess adenoma detection rate, serrated lesion detection, inter- and intraobserver agreement, and procedure-related metrics.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
This prospective randomized controlled study will compare high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), and Spectral Flexible Imaging (SFI) for the detection and optical characterization of colorectal lesions during colonoscopy.
Participants will be randomized in a 1:1:1 ratio to one of the three imaging modalities. During the first-look withdrawal phase, the colon will be examined using the allocated modality. Detected lesions will be documented and characterized in vivo according to their location, size, morphology, and established endoscopic classification systems, including the Paris, Kudo, and JNET classifications. Lesions will subsequently be biopsied or resected as clinically appropriate and submitted for histopathological evaluation, which will serve as the reference standard for diagnostic performance analyses.
Standardized recordings of colorectal lesions will also be used for blinded review to assess interobserver and intraobserver agreement in optical diagnosis and endoscopic classification. In addition to evaluating lesion detection and characterization, the study will compare procedural quality metrics and safety across the imaging modalities.
The study is designed to determine whether VIST or SFI can improve colorectal lesion detection and optical characterization compared with conventional high-definition white light endoscopy.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
990
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.
Estudio Contacto
- Nombre: Ari Ben Hur Stefani Leão, MD
- Número de teléfono: +55 51 3195 2843
- Correo electrónico: gpeg.pucrs@gmail.com
Ubicaciones de estudio
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90160-090
- Hospital Sao Lucas da PUCRS
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Contacto:
- Ari Ben Hur Stefani Leão, MD
- Número de teléfono: +55 51 3195 2843
- Correo electrónico: gpeg.pucrs@gmail.com
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Undergoing screening or surveillance colonoscopy
- Adequate bowel preparation (Boston Bowel Preparation Scale ≥6, with ≥2 per segment)
- Ability to understand and sign informed consent
Exclusion Criteria:
- History of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Prior colorectal resection
- Colorectal stenosis preventing scope progression
- Pregnancy or breastfeeding
- Inadequate bowel preparation
- Clinical contraindication to colonoscopy
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: White Light Endoscopy (WLE)
Participants randomized to this arm will undergo colonoscopy using high-definition white light endoscopy (WLE) during the first-look withdrawal phase.
Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol.
Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
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Colonoscopy performed using high-definition white light imaging.
Otros nombres:
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Experimental: Versatile Intelligent Staining Technology (VIST)
Participants randomized to this arm will undergo colonoscopy using Versatile Intelligent Staining Technology (VIST) during the first-look withdrawal phase.
Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol.
Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
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Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Otros nombres:
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Experimental: Spectral Flexible Imaging (SFI)
Participants randomized to this arm will undergo colonoscopy using Spectral Flexible Imaging (SFI) during the first-look withdrawal phase.
Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol.
Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
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Colonoscopy performed using Spectral Flexible Imaging (SFI).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adenoma Detection Rate (ADR)
Periodo de tiempo: During index colonoscopy.
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Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
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During index colonoscopy.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serrated Lesion Detection Rate
Periodo de tiempo: During index colonoscopy.
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Proportion of participants with ≥1 serrated lesion (e.g., sessile serrated lesion or hyperplastic polyp) detected during the first-look withdrawal phase using the allocated imaging modality, with histopathology confirmation when available.
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During index colonoscopy.
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Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
Periodo de tiempo: During index colonoscopy with post-procedure histopathology results.
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Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.
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During index colonoscopy with post-procedure histopathology results.
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Agreement Between Optical Diagnosis and Histopathology
Periodo de tiempo: During index colonoscopy with post-procedure histopathology results.
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Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.
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During index colonoscopy with post-procedure histopathology results.
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Concordance of Endoscopic Classifications With Histopathology
Periodo de tiempo: During index colonoscopy with post-procedure histopathology results.
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Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.
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During index colonoscopy with post-procedure histopathology results.
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Interobserver and Intraobserver Agreement From Blinded Video Review
Periodo de tiempo: Up to 12 months after index colonoscopy (video-based assessment).
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Interobserver and intraobserver agreement (Cohen's kappa) for optical diagnosis and classification based on standardized video recordings of lesions reviewed independently and blinded to group allocation and histopathology.
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Up to 12 months after index colonoscopy (video-based assessment).
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Procedure Quality Metrics
Periodo de tiempo: During index colonoscopy.
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Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.
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During index colonoscopy.
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Safety (Procedure-related Adverse Events)
Periodo de tiempo: Up to 24 hours after colonoscopy.
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Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).
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Up to 24 hours after colonoscopy.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
31 de enero de 2027
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
1 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Condiciones Patológicas, Anatómicas
- Enfermedades intestinales
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias Glandulares y Epiteliales
- Enfermedades del Colon
- Pólipos
- Pólipos intestinales
- Condiciones Patológicas, Signos y Síntomas
- Neoplasias colorrectales
- Adenoma
- Pólipos colónicos
Otros números de identificación del estudio
- 00410826.8.0000.5336
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The individual participant data (IPD) sharing plan has not yet been determined.
Any future sharing of de-identified participant data will be subject to applicable ethical and institutional requirements, participant confidentiality protections, and relevant data protection regulations.
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
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