Clinical trial · Interventional
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
NCT02790853CI-TRIAL-00108384active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysplasia | — | UNRESOLVED | — |
| Lip and Oral Cavity Carcinoma | Lip and Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Disorder | — | UNRESOLVED | — |
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Fluorescence Imaging | Procedure | — | UNRESOLVED |
| High-Resolution Microendoscopy | Procedure | — | UNRESOLVED |
| Proflavine Hemisulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (multimodal imaging, biopsy)
- description
- Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.
- interventionNames
- Procedure: Biopsy
- Procedure: Fluorescence Imaging
- Procedure: High-Resolution Microendoscopy
- Drug: Proflavine Hemisulfate
Primary outcomes (1)
- measure
- Detection of high grade dysplasia and carcinoma
- timeFrame
- Up to 2 years
- description
- Will compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who are willing to participate. * Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure. * Ability to understand and willingness to sign a written informed consent document (ICD). Exclusion Criteria: * Known allergy to proflavine or acriflavine. * Pregnant females.
References
Publications (0)
Data not yet available
No reference posted for this study.