NCT07842211Not yet recruiting
Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- 1 Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Anh Le
- Diseases
- Head and neck cancer
- NCT number
- NCT07842211
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 1 Dec 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Currently undergoing treatment for malignancy
Age
- Age: Individuals under 18 years of age.
Other
- Unwilling or unable to provide informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania, Department of Oral & Maxillofacial Surgery/Pharmacology Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.