Using Optical Coherence Tomography to Diagnose Oral Cancer
Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 1 site (Palermo) |
| Trial ID | NCT06321003 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients with suspected potentially malignant oral disorders or oral squamous cell carcinoma who can provide informed consent.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Palermo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.