SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

NCT06321003 | Recruiting

• 1 other identifier: OCT01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Phase I: Standardization of Biopsy and OCT Imaging Techniques

  In Phase I, the focus will be on developing and implementing standardized protocols for biopsy acquisition and OCT imaging. This phase aims to optimize tissue preservation, ensure alignment with OCT imaging parameters, and enhance diagnostic yield through the standardization of site and dimension of optical and surgical sampling. Detailed protocols will be established for both OCT imaging and histological processing of biopsy specimens, laying the foundation for reliable correlation between imaging modalities.

  This outcome will be assessed during the first year of study period.

• Phase II: Development of Standardized OCT Patterns, Creation of Comprehensive Image Repository, and Training Algorithms

  A meticulous analysis of OCT images will be conducted to standardize patterns reflective of various oral lesions. These standardized OCT patterns will not only enhance diagnostic precision but will also serve as the foundation for training algorithms. Concurrently, a robust dataset comprising OCT images and corresponding histological data will be meticulously curated. This comprehensive repository will facilitate the training and validation of machine learning algorithms, aimed at developing sophisticated diagnostic software. By incorporating standardized OCT patterns into algorithm training, clinicians can benefit from automated assistance in interpreting OCT images, thereby improving diagnostic accuracy and efficiency in oral cancer detection. This integrated approach represents a significant advancement in diagnostic methodologies, providing clinicians with robust software tool for early detection and intervention, ultimately enhancing patient outcomes and clinical practice.

  this outcome will be assessed during the second year of study period.

• Phase III: Development and Large-Scale Validation of Diagnostic OCT Software

  In Phase III, the focus shifts towards the development and validation of diagnostic software empowered by the standardized OCT patterns and the comprehensive image dataset. Leveraging machine learning algorithms trained on this dataset, sophisticated diagnostic software will be meticulously designed to detect early signs of oral cancer with high sensitivity and specificity. This software will enable clinicians to efficiently interpret OCT images, providing automated assistance in diagnosis. Furthermore, extensive validation on a large scale will be conducted to ensure the robustness and reliability of the software across diverse clinical settings. By empowering clinicians with this advanced digital tool, Phase III aims to revolutionize oral cancer diagnosis, ultimately leading to improved patient outcomes and the transformation of clinical practice on a global scale.

  this outcome will be assessed during the third year of study period.

Interventions

OCT (Optical Coherence Tomography) DEVICE

OCT diagnosis in oral carcinogenesis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be enrolled at the Department of Precision Medicine in Medical, Surgical and Critical Care (Me.Pre.C.C.) and at the Oral Medicine Clinic of the A.O.U.P. 'Paolo Giaccone' of Palermo, which serves as a primary care clinic. This includes patients visiting the clinic for either their initial consultation or follow-up appointments.

You may qualify if:

• Adult patients with clinical suspicion of potentially malignant oral disorders (OPMDs) and oral squamous cell carcinoma (OSCC).
• Patients able to provide informed consent for participation in the study.
• Availability of complete clinical data and medical records.

You may not qualify if:

• Patients with a previous diagnosis of OSCC/OPMDs and/or who have already undergone treatment.
• Patients with contraindications to the OCT examination for nonpermissive oral localization using the probe.
• Pregnant or breastfeeding women.
• Patients with disabilities, reluctance or difficulties of understanding to follow the procedures of the study and who have not provided a consent.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

University of Palermo

Palermo, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Leukoplakia, Oral; Lichen Planus, Oral; Graft vs Host Disease; Keratosis, Actinic; Actinic cheilitis; Mouth Neoplasms; Mouth Diseases

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Leukoplakia; Precancerous Conditions; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Keratosis

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Vera Panzarella

  University of Palermo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Panzarella

CONTACT

091 6554612; vera.panzarella@unipa.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (RTDb)

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)