Using Optical Coherence Tomography to Diagnose Oral Cancer
Official title: Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer
Run by University of Palermo · NCT06321003 · Data updated 2026-11-12
This study is testing if a special imaging technique called Optical Coherence Tomography can help doctors find oral cancer earlier and more accurately in patients with potentially harmful mouth conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Palermo Academic / other |
| Locations | 1 site (Palermo) |
| Status | Recruiting |
| Started | March 13, 2024 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | May 23, 2025 |
| Trial ID | NCT06321003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients with suspected potentially malignant oral disorders or oral squamous cell carcinoma who can provide informed consent.
✕Probably not a fit
Patients with a prior diagnosis of OSCC or OPMDs, those who have undergone treatment, or individuals with contraindications to OCT will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of Optical Coherence Tomography (OCT) for the early diagnosis of oral cancer, particularly focusing on Oral Potentially Malignant Disorders (OPMDs) that can lead to Oral Squamous Cell Carcinoma (OSCC). The study compares OCT imaging with traditional histology, aiming to create a database of OCT data to enhance non-invasive identification of cancerous changes in oral tissues. By providing detailed cross-sectional images, OCT may improve the accuracy and efficiency of diagnosing early-stage oral lesions, potentially reducing the need for invasive biopsies.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of oral cancer, improving patient outcomes.
How similar studies have gone: While the use of OCT in oral diagnostics is promising, this specific application is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC). 2. Patients able to provide informed consent for participation in the study. 3. Availability of complete clinical data and medical records. Exclusion Criteria: 1. Patients with a previous diagnosis of OSCC/OPMDs and/or who have already undergone treatment. 2. Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe. 3. Pregnant or breastfeeding women. 4. Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.
Where it's running
-
University of Palermo
Palermo, Italy Recruiting
Study contacts
- Principal investigator: Vera Panzarella — University of Palermo
- Study coordinator: Vera Panzarella
- Email: vera.panzarella@unipa.it
- Phone: 091 6554612
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.