Actively Recruiting
Precision Optical Guidance for Oral Biopsy Using the Active Biopsy Guidance System to Evaluate and Optimize Imaging Performance for Oral Lesions
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging device called the Active Biopsy Guidance System to help doctors decide when and where to perform invasive biopsies of mouth lesions. The study aims to assess and improve the technical performance of this system and to provide preliminary estimates of its sensitivity and specificity compared to traditional tissue analysis (histopathology). The device uses optical imaging techniques and an optical contrast agent called proflavine. The Active Biopsy Guidance System consists of two parts: the optical mapping scope and the high-resolution microendoscope (HRME). The optical mapping scope captures wide-area images of the mouth lining by shining different colors of light, while the HRME takes detailed pictures of very small areas at high magnification. During the study, a fluorescent dye called proflavine hemisulfate is applied to mouth areas to enhance image quality. Participants with oral lesions will be involved in imaging sessions using these devices. Researchers will collect images and compare them to biopsy results to measure how accurately the system detects abnormalities. The study will continue for about one year, monitoring the device's performance. Safety and participant consent will be carefully managed throughout the trial.
CONDITIONS
Brief Title
Precision Optical Guidance for Oral Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects with visible oral lesions such as leukoplakia, erythroplakia, oral potentially malignant disorders like lichen planus and graft vs. host disease, or a history of oral cancer or dysplasia
- Adults previously treated with surgery, radiation, chemotherapy, or other therapies are eligible
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Known allergy to proflavine or acriflavine
- Age under 18 years
- Pregnant or nursing females
- Adults unable to provide consent
- Prisoners and other vulnerable populations excluded from participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 day
Participants undergo imaging using the Active Biopsy Guidance System, which includes the optical mapping scope and the high resolution microendoscope (HRME). A fluorescent dye called proflavine hemisulfate is applied to areas of the mouth to enhance imaging.
1 visit (in-person)
Duration - Up to 1 year
Participants are followed for up to 1 year to estimate the sensitivity and specificity of the imaging system with respect to histopathology.
Follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ann Gillenwater, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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