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NCT00601185 Clinical Trial

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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00601185
Other study ID # 06-009
Secondary ID NIH R01 EB0027-1
Status Completed
Phase N/A
First received January 14, 2008
Last updated February 26, 2018
Start date February 14, 2006
Est. completion date February 23, 2018

Study information
Verified date February 2018
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date February 23, 2018
Est. primary completion date February 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• confocal 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.

Locations
Country Name City State
United States 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

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo. conclusion of study
Secondary 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
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