Precision Optical Guidance for Oral Biopsy

ConditionOral Lesions

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Known allergy to proflavine or acriflavine.

Age less than 18 years.

Pregnant or nursing females.

Adults unable to consent

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: The Active Biopsy Guidance SystemExperimental treatment 3 interventions

Trial 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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Source ClinicalTrials.gov

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