RecruitingNCT06321003

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

Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer


Sponsor

University of Palermo

Enrollment

200 participants

Start Date

Mar 13, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study uses optical coherence tomography (OCT) — a non-invasive light-based imaging technology, similar to an ultrasound but using light — combined with machine learning to detect potentially cancerous or pre-cancerous lesions in the mouth more accurately. **You may be eligible if...** - You are an adult with a suspected potentially malignant oral lesion or oral squamous cell carcinoma (mouth cancer) - You are able to give informed consent - You have complete clinical data and medical records available **You may NOT be eligible if...** - You have already been diagnosed with oral cancer or pre-cancer and have received treatment - The location of your lesion cannot be reached safely with the OCT probe - You are pregnant or breastfeeding - You are unable to understand or follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOCT (Optical Coherence Tomography)

OCT diagnosis in oral carcinogenesis


Locations(1)

University of Palermo

Palermo, Italy

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NCT06321003


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