Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue Health Condition 2: K135- Oral submucous fibrosis
Conditions
Interventions
None listed
Sponsors
National Institutes of Health, United States
Eligibility
Inclusion criteria
Inclusion criteria: 1. ALl individuals above 18 years and having Clinically suspicious oral lesions which are indicated for biopsy.
Exclusion criteria
Exclusion criteria: 1. Individuals less than 18 years 2. Pregnant women 3. Individuals currently undergoing treatment for malignancy 4. Individuals having acute illness or undergoing treatment for tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proposed dual mode intraoral imaging system will deliver new & imperatively needed capabilities to the end users in low resource setting. This artificial intelligence integrated system will: (1) detect suspicious regions with high sensitivity & specificity; (2) enable automatic, accurate, & objective in situ diagnosis; & in screening program settings or nodal center settings, the device will triage suspicious or non-suspicious lesions. Timepoint: 1. Optimize a mobile imaging system for low-resource setting in year 1 2. Develop mobile based deep learning image classification in year 1 3. Validate the clinical usefulness of the mobile imaging system in year 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Final outcome of the study is to achieve Diagnostic sensitivity & specificity of: 1) 95 % for distinguishing OSCC from healthy sites; (2) 90% for distinguishing OPML from healthy tissues; and (3) 85% for distinguishing non-neoplastic lesion from healthy, oral cancer, or OPML tissues.Timepoint: The diagnostic accuracy, sensitivity & specificity will be achieved at the end of second year | — |
Countries
India
Contacts
Public ContactDr Amritha Suresh
KLE Societys Institute of Dental Sciences
Outcome results
None listed