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RecruitingNot ApplicableNCT05554133

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

90 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

Conditions

Oral Lesions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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).

Exclusion Criteria5

  • Known allergy to proflavine or acriflavine.
  • Age less than 18 years.
  • Pregnant or nursing females.
  • Adults unable to consent
  • Prisoners and other vulnerable populations

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Interventions

DEVICEHigh 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.

DEVICEOptical 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.

DRUGProflavine 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

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05554133