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

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Malignant Skin Disorders Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

confocal microscopy in vivo

Procedure

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.

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2018
Study completion: 2018
First posted: Jan 25, 2008
Registry last updated: Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed