Precision Optical Guidance for Oral Biopsy

ConditionOral Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Ability to understand and willingness to sign a written Informed Consent Document (ICD).

Disqualifiers

Known allergy to proflavine or acriflavine.

Age less than 18 years.

Pregnant or nursing females.

Adults unable to consent

Trial design

Treatments tested in this trial

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

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator