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 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
990
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ari Ben Hur Stefani Leão, MD
- Numéro de téléphone: +55 51 3195 2843
- E-mail: gpeg.pucrs@gmail.com
Lieux d'étude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90160-090
- Hospital Sao Lucas da PUCRS
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Contact:
- Ari Ben Hur Stefani Leão, MD
- Numéro de téléphone: +55 51 3195 2843
- E-mail: gpeg.pucrs@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
Colonoscopy performed using high-definition white light imaging.
Autres noms:
|
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Expérimental: 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.
|
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Autres noms:
|
|
Expérimental: 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.
|
Colonoscopy performed using Spectral Flexible Imaging (SFI).
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adenoma Detection Rate (ADR)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serrated Lesion Detection Rate
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
31 janvier 2027
Achèvement de l'étude (Estimé)
31 août 2028
Dates d'inscription aux études
Première soumission
26 août 2026
Première soumission répondant aux critères de contrôle qualité
26 août 2026
Première publication (Réel)
1 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Conditions pathologiques, anatomiques
- Maladies intestinales
- Tumeurs par type histologique
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs intestinales
- Maladies rectales
- Tumeurs, glandulaires et épithéliales
- Maladies du côlon
- Polypes
- Polypes intestinaux
- Conditions pathologiques, signes et symptômes
- Tumeurs colorectales
- Adénome
- Polypes coliques
Autres numéros d'identification d'étude
- 00410826.8.0000.5336
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .