Clinical trial · Interventional
Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery
Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
- 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 wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Neoplasm | Oral Cavity Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Resolution Microendoscopy | Procedure | — | UNRESOLVED |
| Multispectral Imaging | Procedure | — | UNRESOLVED |
| Proflavine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (widefield multispectral imaging and HRME)
- description
- Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
- interventionNames
- Procedure: High-Resolution Microendoscopy
- Procedure: Multispectral Imaging
- Drug: Proflavine
Primary outcomes (2)
- measure
- Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine.
- timeFrame
- 1 day
- description
- Images obtained will be compared against the histology slides of tissue taken from the same region.
- measure
- Classification of tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head \& neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible * Ability to understand and the willingness to sign a written informed consent document (ICD) Exclusion Criteria: * Known allergy to proflavine or acriflavine * Pregnant or nursing females * The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
References
Publications (0)
Data not yet available