Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.

Memorial Sloan Kettering Cancer Center116 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

116

Conditions

Basal Cell Carcinoma Melanoma Squamous Cell Carcinoma Non-Malignant Skin Disorders

Interventions

confocal microscopy in vivoPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (4)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering West Harrison

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center Hauppauge

Hauppauge, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.

Time frame: conclusion of study

Secondary Outcomes

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.

Time frame: conclusion of study

Data from ClinicalTrials.gov

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