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

NCT ID: NCT00601185

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-14

Study Completion Date

2018-02-23

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients undergoing a shave biopsy and confocal microscopy.

confocal microscopy in vivo

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kishwer Nehal, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering West Harrison

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center Hauppauge

Hauppauge, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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NIH R01 EB0027-15,

Identifier Type: -

Identifier Source: secondary_id

R44 CA093106-02c

Identifier Type: -

Identifier Source: secondary_id

R44CA093106-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-009

Identifier Type: -

Identifier Source: org_study_id

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