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NCT05554133 | Recruiting | Oral Lesions

Precision Optical Guidance for Oral Biopsy
Sponsor:

M.D. Anderson Cancer Center

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.

Condition or disease

Oral Lesions

Intervention/treatment

High Resolution Microendoscope (HRME)

Optical Mapping Scope

Proflavine hemisulfate

Phase

Not Applicable

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).}}

Study Type : Interventional
Estimated Enrollment : 90 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : 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
Actual Study Start Date : June 15, 2023
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025
Arm Intervention/treatment

Experimental: The Active Biopsy Guidance System

This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):

Device: High Resolution Microendoscope (HRME)

Device: Optical Mapping Scope

Drug: Proflavine hemisulfate
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 Criteria
  • Known allergy to proflavine or acriflavine.
  • Age less than 18 years.
  • Pregnant or nursing females.
  • Adults unable to consent
  • Prisoners and other vulnerable populations
Precision Optical Guidance for Oral Biopsy

Location Details

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Precision Optical Guidance for Oral Biopsy

How to Participate

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Locations

Recruiting

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030