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

Completed

• Conditions: Basal Cell Carcinoma; Melanoma; Squamous Cell Carcinoma; Non-Malignant Skin Disorders
• Interventions: Procedure: confocal microscopy in vivo

• Registration Number: NCT00601185
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Status Verified: 2018-02
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	confocal microscopy in vivo	Patients undergoing a shave biopsy and confocal microscopy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Memorial Sloan Kettering Cancer Center Hauppauge; 🇺🇸 Hauppauge, New York, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States