Actively Recruiting
Single-blind Clinical Trial Assessing the Validity of Optical Coherence Tomography (OCT) in Diagnosing Potentially Malignant Oral Lesions and Oral Cancer
Led by University of Palermo · Updated on 2025-05-23
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Optical Coherence Tomography (OCT) for early diagnosis of oral cancer, focusing on oral potentially malignant disorders (OPMDs) and oral squamous cell carcinoma (OSCC). Despite existing oral screening methods, delays in diagnosis remain common, so this study aims to explore OCT as a non-invasive imaging tool that provides detailed cross-sectional views of oral tissues. The trial also integrates Artificial Intelligence (AI) to improve image analysis and speed up diagnosis, seeking to establish standardized OCT patterns correlated with histology, the current gold standard for diagnosis. Participants will undergo OCT scans alongside traditional biopsy and histological analysis using a standardized procedure to ensure accurate comparison between imaging and tissue analysis. The study is organized in phases: the first year focuses on standardizing OCT and biopsy techniques; the second year develops standardized OCT patterns and builds a comprehensive image dataset; and the third year involves developing and validating diagnostic software using machine learning algorithms. This approach aims to create reliable diagnostic tools that enhance early detection of oral cancer. During the study, participants will receive OCT imaging and biopsies following the standardized protocol, with clinical data and medical records collected. Researchers will compare OCT images with histological findings to identify characteristic tissue features and train AI algorithms. The primary outcomes include standardizing techniques, creating an image repository, and validating diagnostic software. The study is observational and will monitor participants with suspected oral lesions to improve non-invasive diagnostic methods over approximately three years.
CONDITIONS
Brief Title
SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo Optical Coherence Tomography (OCT) imaging of oral lesions as part of standardized diagnostic procedures, including targeted biopsy acquisition for correlation with histological analysis.
Multiple visits over the study period for OCT imaging and biopsy procedures
Duration - Up to 3 years
Participants' OCT images and biopsy results are collected and analyzed over time to develop and validate standardized OCT patterns and diagnostic software for oral cancer detection.
Follow-up visits as scheduled during the study period for imaging and assessment
Trial Site Locations
Total: 1 location
1
University of Palermo
Palermo, Italy
Actively Recruiting
Research Team
V
Vera Panzarella
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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