Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oral Tissue
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- number of images with acceptable quality
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy."
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers
- •Ability to sign informed consent
- •Age ≥ 18 years.
Exclusion Criteria
- •Inability to give informed consent.
- •Previously known oral disease
Outcomes
Primary Outcomes
number of images with acceptable quality
Time Frame: 1 year
Each image will be scored either 1 (completely unacceptable), 2 (unacceptable), 3 (possibly acceptable), 4 (acceptable) or 5 (very acceptable) relative to a reference standard The reference standard for appearance of adequate sectioning, resolution and contrast and for detectability of nuclear and cellular features will be the appearance of images and image quality, which we are intimately familiar with, based on the past several years of experience with the existing RCM device for which images of oral mucosa have been well-characterized, well-correlated to histology, and thus are well-understood.