Precision Optical Guidance for Oral Biopsy

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Oral Lesions

Treatments: Device: Optical Mapping Scope; Device: High Resolution Microendoscope (HRME); Drug: Proflavine hemisulfate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05554133

R01DE029590-01 (U.S. NIH Grant/Contract)

2020-1115

NCI-2022-07929 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

The Active Biopsy Guidance System

Experimental group

Description:

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

Treatment:

Drug: Proflavine hemisulfate

Device: High Resolution Microendoscope (HRME)

Device: Optical Mapping Scope