Clinical trial Recruiting at 1 site Observational Ages 18 to 99

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 typeObservational
Ages18 Years to 99 Years
SexAll
Enrollment200 (estimated)
SponsorUniversity of Palermo
Academic / other
Locations1 site (Palermo)
StatusRecruiting
StartedMarch 13, 2024
Main results expectedApril 1, 2027
Study endsApril 1, 2028
Registry record updatedMay 23, 2025
Trial IDNCT06321003 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.