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

Anh Le

Status: Begins enrollment in 1 month

Conditions: Oral Potentially Malignant Disorders; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer; Oral Potentially Malignant Lesions; Oral Cancer

Treatments: Device: Deep UV-M and AI Cytology Triage

Study type: Interventional

Funder types: Other

Identifiers

NCT07842211

26-6563

Details and patient eligibility

About

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.

Full description

This research project establishes a new diagnostic paradigm by transforming oral brush cytology from a centralized, laboratory-dependent procedure into an automated, AI-assisted point-of-care (POC) triage system. Traditional brush cytology relies on chemical staining, physical sample shipping, and off-site expert review, which can introduce diagnostic turnaround delays. By combining label-free optical imaging with automated hardware and deep learning, this system aims to deliver immediate, same-visit triage of suspicious oral lesions directly within primary dental and outpatient clinics.

Optical Physics & Optomechanical Engineering: The core imaging system utilizes Deep Ultraviolet (DUV) microscopy operating in the 200-280 nm spectral range. At these wavelengths, cellular nucleic acids and proteins exhibit strong intrinsic light absorption, enabling submicron-resolution, high-contrast visualization of nuclear architecture without chemical dyes or fluorescent stains.

Transformer-Based AI Framework (CellViT): Cellular analysis and classification are powered by an adapted CellViT deep learning framework, which replaces traditional object-detection architectures like YOLOv7.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Suspicious Lesions Cohort: Adults with suspicious oral potentially malignant lesions (OPML), such as leukoplakia, erythroplakia, or speckled lesions), oral precancer (dysplasia), or suspected oral/oropharyngeal squamous cell carcinoma (OSCC) who are scheduled for a diagnostic incisional or excisional tissue punch biopsy.
• Healthy Volunteers Cohort: Clinically normal volunteers without suspicious oral mucosal lesions.

Exclusion criteria

• Age: Individuals under 18 years of age.
• Currently undergoing treatment for malignancy
• Unwilling or unable to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

AI-Enabled Deep UV Brush Cytology with Biopsy Validation

Experimental group

Description:

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.

Treatment:

Device: Deep UV-M and AI Cytology Triage