NCT05554133

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Oral Lesions

Interventions

Type	Name	Description
DEVICE	High 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.
DEVICE	Optical 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.
DRUG	Proflavine 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

Timeline

• Start date: 2023-06-15
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2022-09-26
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study