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Precision Optical Guidance for Oral Biopsy

Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• High Resolution Microendoscope (HRME) (device)
• Optical Mapping Scope (device)
• Proflavine hemisulfate (drug)

Sponsor: M.D. Anderson Cancer Center · Participants: 90 · Started: Jun 15, 2023

Contact the study team

• Ann Gillenwater, MD · Phone: (713) 792-8841

Official record on ClinicalTrials.gov — NCT05554133

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.