Basal Cell Carcinoma, Melanoma, Non-Malignant Skin Disorders, Squamous Cell Carcinoma
Conditions
Keywords
06-009, Confocal reflectance microscopy, shave-biopsy
Brief summary
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.
Interventions
PROCEDUREconfocal microscopy in vivo
A dermatologist will perform a shave biopsy according to standard clinical procedures. This study will be carried out after the shave biopsy. The deep surface and the peripheral margins will be imaged on each patient.
Sponsors
National Institutes of Health (NIH)
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead). * The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope. * Ability to sign informed consent. * Age ≥ 18 years.
Exclusion criteria
* Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes). * Inability to give informed consent. * Known hypersensitivity to adhesive rings. * Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo. | conclusion of study |
Secondary
| Measure | Time frame |
|---|---|
| To assess the quality of the CSLM images of the biopsy sites to determine a point estimate of the proportion of images that will be of acceptable quality for formal analysis in the planned study of intraoperative margin detection. | conclusion of study |
Countries
United States
Outcome results
None listed