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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05554133

Enrollment

Registered

2022-09-26

Start date

2023-06-15

Completion date

2027-03-31

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lesions

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.

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).

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Contacts

CONTACTAnn Gillenwater, MD

agillenw@mdanderson.org(713) 792-8841

PRINCIPAL_INVESTIGATORAnn Gillenwater, MD

MD Anderson Caner Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026