Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage

Study acronym: DEEP UV-M
StatusNot Yet Recruiting
PhaseNot applicable
SponsorAnh Le
Started

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Record History

  1. Minor Study First Submitted
This research study evaluates an experimental, point-of-care tool that combines Deep Ultraviolet (DUV) light imaging with Artificial Intelligence (AI) to rapidly screen for oral cancer and pre-cancer (dysplasia). The main goal is to determine if this automated tool can accurately deliver immediate, same-visit triage results (categorizing cells as either non-dysplasia or dysplasia/cancer) without needing chemical stains, sample transport, or off-site laboratory processing. The following occurs during a singular clinic visit for participants: 1. Minimally Invasive Brush Test: A clinician gently rotates a soft brush over the mouth tissue to collect surface cells. 2. Stain-Free Imaging \& AI Analysis: The DUV microscope scans the unstained cells in minutes, and the AI analyzes cell features (such as nucleus size and shape) in under 10 seconds. 3. Standard Medical Care: Participants with suspicious spots receive a standard tissue biopsy to ensure a definitive, confirmed diagnosis regardless of the AI result. This is important given that the five-year survival rates for oral cancer exceed 80% when caught early but drop to under 20% if detected late. By delivering rapid results directly at the clinic, this technology aims to eliminate long waiting periods for lab results, accelerate specialist referrals, and improve access to early screening in community dental and medical clinics.
Trial Details
NCT Number NCT07842211
Lead Sponsor Anh Le
Collaborators: University of Arizona
Conditions
(from sponsor)
Oral Potentially Malignant Lesions, Oral Potentially Malignant Disorders, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oral Cancer
Related terms Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov