Precision Optical Guidance for Oral Biopsy

M.D. Anderson Cancer Center90 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Oral Lesions

Interventions

High Resolution Microendoscope (HRME)DEVICE

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.

Optical Mapping ScopeDEVICE

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.

Proflavine hemisulfateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology

Time frame: Through study completion an average of 1 year.

Central Contacts

Ann Gillenwater, MD

CONTACT

(713) 792-8841 agillenw@mdanderson.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.