AI-Enabled DUV Cytology for Oral Cancer
(DEEP UV-M Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Anh D Le, DDS, PhD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for people with mouth sores or suspected oral cancers, including pre-cancerous conditions like leukoplakia. Participants must be able to visit the clinic for a brush test and follow-up care. Specific inclusion and exclusion criteria are not detailed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Deep UV-M and AI Cytology Triage
Trial Overview
The study tests a new tool that uses deep ultraviolet light and AI to quickly analyze cells from a gentle mouth brush test, aiming to spot early signs of oral cancer or pre-cancer during one clinic visit without sending samples to a lab.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with suspicious oral lesions undergo a quick, non-invasive oral brush test analyzed in real time by the experimental Deep UV AI platform. Immediately after, participants receive the routine 5 mm tissue biopsy to confirm their diagnosis. The AI scan result is compared directly against the biopsy pathology to measure the AI's diagnostic accuracy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anh Le
Lead Sponsor
University of Arizona
Collaborator
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