NCT05554133NARecruiting
Precision Optical Guidance for Oral Biopsy
M.D. Anderson Cancer Center
Start Date
6/15/2023
Completion Date
3/31/2027
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.
Detailed Description
Primary objective: -To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System. Secondary objective: -To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DEVICE
High Resolution Microendoscope (HRME)
DEVICE
Optical Mapping Scope
DRUG
Proflavine hemisulfate
Conditions
Oral Lesions
Locations
M D Anderson Cancer Center
Houston, Texas 77030
United States