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NCT Number: NCT05554133

Precision Optical Guidance for Oral Biopsy

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.

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Key information

Conditions

Oral Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Ann Gillenwater, MD

CONTACT

[email protected]

713-792-8841

Ann Gillenwater, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Scope

Device

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 Hemisulfate

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Gillenwater, MD

CONTACT

[email protected]

(713) 792-8841

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2022
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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