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Digital Infrared Imaging system for screening and early detection of oral cancer

Design and development of a safe, portable, economical, non-invasive, Point of Care digital infrared imaging system for screening and early detection of oral cancer: An exploratory pilot study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/04/051533
Enrollment
800
Registered
2023-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

None listed

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Study Subjects: 1.Adult patients 18 years and above 2.Confirmed diagnosis of inflammatory/ vascular, potentially malignant and malignant oral lesions as per current WHO diagnostic criteria Healthy controls: 1.Healthy controls would also be recruited from patients who are reporting to CDER for other routine dental problems, without any type of oral lesions (developmental, traumatic, infectious, reactive, inflammatory, vascular, autoimmune, potentially malignant, malignant) as seen by clinical oral examination

Exclusion criteria

Exclusion criteria: 1. Subjects not willing to participate in the study 2. Subjects with complete trismus 3. Subjects febrile with acute inflammatory oral conditions 4. Subjects with recent history of facial trauma, major intraoral or extraoral surgery 5. Subjects with past history of oral malignancy 6. Subjects who require immediate medical attention for emergency oral/systemic conditions 7. Pregnant women and children

Design outcomes

Primary

MeasureTime frame
Positive: Malignant oral present Negative: Normal/ Benign Inconclusive: UnknownTimepoint: 18 months; 36 months

Secondary

MeasureTime frame
Superimposition of the two biopsy site areas selected on clinical and infrared images Score 76-100% 4 Excellent 51-75% 3 V Good 26-50% 2 Good 1-25% 1 Fair 0% 0 Poor Timepoint: 3 years

Countries

India

Contacts

Public ContactDr Shalini Gupta

All India Institute of Medical Sciences New Delhi

shalinigupta@hotmail.com9971904592

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026