Recruiting

Imaging Device

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05554133

Conditions

Oral Lesions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Resolution Microendoscope (HRME)

Optical Mapping Scope

Proflavine hemisulfate

Study Details

Brief summary:

To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Conditions

Oral Lesions

Study ID

NCT05554133

Start date

Jun 15, 2023

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

1. Known allergy to proflavine or acriflavine.
2. Age less than 18 years.
3. Pregnant or nursing females.
4. Adults unable to consent
5. Prisoners and other vulnerable populations

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: The Active Biopsy Guidance System

This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):

Interventions

High Resolution Microendoscope (HRME)

The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification.

Optical Mapping Scope

The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.

Proflavine hemisulfate

A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures

Primary outcome measure

  • To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology [ Time Frame: Through study completion an average of 1 year. ]

Central Contacts and Locations

Central contacts

Ann Gillenwater, MD

(713) 792-8841agillenw@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ann Gillenwater, MD

713-792-8841agillenw@mdanderson.org

Principal Investigator:

Ann Gillenwater, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.