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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 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

990

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Brazilië
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië, 90160-090
        • Hospital Sao Lucas da PUCRS
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Apparaat: White Light Endoscopy
Colonoscopy performed using high-definition white light imaging.
Andere namen:
  • WLE
Experimenteel: 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.
Apparaat: Versatile Intelligent Staining Technology
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Andere namen:
  • VIST
Experimenteel: 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.
Apparaat: Spectral Flexible Imaging
Colonoscopy performed using Spectral Flexible Imaging (SFI).
Andere namen:
  • SFI

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adenoma Detection Rate (ADR)
Tijdsspanne: During index colonoscopy.
Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
During index colonoscopy.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Serrated Lesion Detection Rate
Tijdsspanne: During index colonoscopy.
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.
During index colonoscopy.
Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
Tijdsspanne: During index colonoscopy with post-procedure histopathology results.
Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.
During index colonoscopy with post-procedure histopathology results.
Agreement Between Optical Diagnosis and Histopathology
Tijdsspanne: During index colonoscopy with post-procedure histopathology results.
Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.
During index colonoscopy with post-procedure histopathology results.
Concordance of Endoscopic Classifications With Histopathology
Tijdsspanne: During index colonoscopy with post-procedure histopathology results.
Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.
During index colonoscopy with post-procedure histopathology results.
Interobserver and Intraobserver Agreement From Blinded Video Review
Tijdsspanne: Up to 12 months after index colonoscopy (video-based assessment).
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.
Up to 12 months after index colonoscopy (video-based assessment).
Procedure Quality Metrics
Tijdsspanne: During index colonoscopy.
Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.
During index colonoscopy.
Safety (Procedure-related Adverse Events)
Tijdsspanne: Up to 24 hours after colonoscopy.
Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).
Up to 24 hours after colonoscopy.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alexandre Vontobel Padoin

Medewerkers

Hospital Sao Lucas da PUCRS

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 januari 2027

Studie voltooiing (Geschat)

31 augustus 2028

Studieregistratiedata

Eerst ingediend

26 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2026

Eerst geplaatst (Werkelijk)

1 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 september 2026

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 00410826.8.0000.5336

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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