Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT01269190

Conditions

Oral Cavity Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Resolution Microendoscopy

Multispectral Imaging

Proflavine

Study Details

Brief summary:

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

Oral Cavity Neoplasm

Study ID

NCT01269190

Start date

Dec 30, 2010

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

275 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

High-Resolution Microendoscopy

Undergo evaluation of oral lesions using a high-resolution microendoscope

Multispectral Imaging

Undergo evaluation of oral cavity using a widefield multispectral imaging

Proflavine

Proflavine) used to stain the mouth tissue after initial imaging.

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 ]
  • Classification of tissue [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Ann Gillenwater

713-792-8841agillenw@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ann M. Gillenwater

713-792-8841

Principal Investigator:

Ann M. Gillenwater

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-29.