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Recruiting NCT05554133

Precision Optical Guidance for Oral Biopsy

Trial Parameters

Condition Oral Lesions
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-06-15
Completion 2027-03-31
Interventions
High Resolution Microendoscope (HRME)Optical Mapping ScopeProflavine hemisulfate

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.

Eligibility Criteria

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

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