Clinical trial · Interventional
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
The Role of Direct Visual Fluorescence in Oral Examination
NCT01816841CI-TRIAL-00043093completedN/AClinicalTrials.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 clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.
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 |
|---|---|---|---|
| Lip and Oral Cavity Squamous Cell Carcinoma | Lip and Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Cavity Verrucous Carcinoma | Oral Cavity Verrucous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage 0 Lip and Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.78 |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| Comparison of surgical margins by COE vs. DVFE | Procedure | — | UNRESOLVED |
| examination | Procedure | — | UNRESOLVED |
| fluorescence imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diagnostic (COE and DVFE)- Arm I
- description
- Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.
- interventionNames
- Procedure: fluorescence imaging
- Procedure: biopsy
- Procedure: examination
- type
- EXPERIMENTAL
- label
- Arm II - Comparison of surgical margins using COE vs. DVFE
- description
- Comparison of surgical margins using COE vs. DVFE
- interventionNames
- Procedure: fluorescence imaging
- Procedure: biopsy
- Procedure: examination
- Procedure: Comparison of surgical margins by COE vs. DVFE
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HIGH-RISK POPULATION: * 33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate * GENERAL POPULATION: * 250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate
References
Publications (0)
Data not yet available
No reference posted for this study.