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

Memorial Sloan Kettering Cancer Center4 sites in 1 country116 target enrollmentFebruary 14, 2006

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Basal Cell Carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 116
Locations: 4
Primary Endpoint: is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 14, 2006

End Date

February 23, 2018

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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).

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.(conclusion of study)