Clinical trial · Interventional
Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Potentially Malignant Disorders | — | UNRESOLVED | — |
| Oral Potentially Malignant Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep UV-M and AI Cytology Triage | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AI-Enabled Deep UV Brush Cytology with Biopsy Validation
- 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.
- interventionNames
- Device: Deep UV-M and AI Cytology Triage
Primary outcomes (1)
- measure
- Triage Classification
- timeFrame
- From the time of oral brush cytology sampling on Day 1 through completion of the reference biopsy histopathology report, assessed up to 14 days post-procedure.
- description
- The primary endpoint is the accurate binary triage classification (distinguishing non-dysplasia from dysplasia/cancer) performed by the AI DUV-M platform, compared against the reference standard of histopathology.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available