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

This study is currently recruiting participants.
Verified December 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00601185
First received: January 14, 2008
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Basal Cell Carcinoma
Melanoma
Squamous Cell Carcinoma
Non-Malignant Skin Disorders
Procedure: confocal microscopy in vivo

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2006
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients undergoing a shave biopsy and confocal microscopy.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 30 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601185

Contacts
Contact: Kishwer Nehal, MD 212-610-0782
Contact: Allan Halpern, MD 212-610-0766

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kishwer Nehal, MD    212-610-0782      
Contact: Allan Halpern, MD    212-610-0766      
Principal Investigator: Kishwer Nehal, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Kishwer Nehal, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00601185     History of Changes
Other Study ID Numbers: 06-009, NIH R01 EB0027-15,, R44 CA093106-02c
Study First Received: January 14, 2008
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
06-009
Confocal reflectance microscopy
shave-biopsy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Melanoma
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014