AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions

Sponsor
Istituto Italiano di Tecnologia
Study ID
NCT07596355
Status
Not Yet Recruiting

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Conditions

  • Head and Neck Cancer (H&N)
  • Leukoplakia
  • Squamous Cell Carcinoma
  • Upper Aero-digestive Tract (UADT) Neoplasm
  • Upper Aerodigestive Tract Neoplasms
  • Upper AerodigestiveTract Cancer
  • Vocal Cord Disease
  • Vocal Fold Nodules
  • Vocal Fold Polyp

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This is a prospective observational clinical study designed to evaluate the performance of artificial intelligence (AI) algorithms applied to upper aerodigestive tract (UADT) video-endoscopy. The study assesses three main tasks: lesion detection (localization), classification (benign vs malignant), and segmentation of tumor margins. AI algorithms will be applied to endoscopic video data acquired during routine clinical practice without influencing clinical decision-making. The system will process images in real time and store data for subsequent analysis. AI outputs will be compared with physician assessment and reference standard histopathology to evaluate diagnostic performance.

Key Dates

First listed
May 19, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
283 participants (estimated)

Primary Outcome Measure

Negative Predictive Value of the CADx Algorithm for Malignant or Premalignant Upper Aerodigestive Tract Lesions [ Time Frame: From index outpatient UADT video-endoscopy until definitive histopathology result is available, assessed up to 60 days after endoscopy. ]

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