Precision Optical Guidance for Oral Biopsy

NCT05554133 | Recruiting FDA Device

• 3 other identifiers: 2020-1115NCI-2022-07929R01DE029590-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lesions

Outcome Measures

Primary Outcomes (1)

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

  Through study completion an average of 1 year.

Study Arms (1)

The Active Biopsy Guidance System

EXPERIMENTAL

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

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.

The Active Biopsy Guidance System

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.

The Active Biopsy Guidance System

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

The Active Biopsy Guidance System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Proflavine

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ann Gillenwater, MD

  MD Anderson Caner Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Gillenwater, MD

CONTACT

(713) 792-8841; agillenw@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 26, 2022
• Study Start: June 15, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)