Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer
Trial ID: NCT06321003
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2024-03-13
Completion date: 2028-04-01
Sponsor: University of Palermo
Conditions: Oral Squamous Cell Carcinoma; Oral Potentially Malignant Disorder; Oral Leukoplakia; Proliferative Verrucous Leukoplakia; Oral Lichen Planus; Oral Lichenoid Lesion; Graft-versus-host-disease; Oral Erythroplakia; Actinic Keratoses; Actinic Cheilitis; Oral Cancer; Oral Disease
Interventions: OCT (Optical Coherence Tomography)
Locations: University of Palermo
Countries: Italy
Enrollment: 200
Age range: 18 Years - 99 Years
Sex: ALL

Summary:
This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.

The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.

Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.

In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.

Eligibility 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.

Outcomes:
Phase I: Standardization of Biopsy and OCT Imaging Techniques; Phase II: Development of Standardized OCT Patterns, Creation of Comprehensive Image Repository, and Training Algorithms; Phase III: Development and Large-Scale Validation of Diagnostic OCT Software