Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

Conditions

• Oral Cavity Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• High-Resolution Microendoscopy — PROCEDURE
  Undergo evaluation of oral lesions using a high-resolution microendoscope
• Multispectral Imaging — PROCEDURE
  Undergo evaluation of oral cavity using a widefield multispectral imaging
• Proflavine — DRUG
  Proflavine) used to stain the mouth tissue after initial imaging.

Study Details

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.

Key Dates

Start date

Dec 30, 2010

Status verified

Feb 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

275 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Diagnostic (widefield multispectral imaging and HRME)
  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.

Primary Outcome 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. [ Time Frame: 1 day ]

Central Contacts

• Ann Gillenwater
  713-792-8841
  [email protected]

Locations (1)

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