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

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ClinicalTrials.gov Identifier: NCT00601185
Recruitment Status : Recruiting
First Posted : January 25, 2008
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo
Actual Study Start Date : February 2006
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dermatology clinic
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 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601185


Contacts
Contact: Kishwer Nehal, MD 646-888-6019
Contact: Allan Halpern, MD 646-888-6013

Locations
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Kishwer Nehal, MD    646-888-6019      
United States, New York
Memorial Sloan Kettering West Harrison Recruiting
Harrison, New York, United States, 10604
Contact: Kishwer Nehal, MD    646-888-6019      
Memorial Sloan Kettering Cancer Center Hauppauge Recruiting
Hauppauge, New York, United States, 11788
Contact: Kishwer Nehal, MD    646-888-6019      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kishwer Nehal, MD    646-888-6019      
Contact: Allan Halpern, MD    646-888-6013      
Principal Investigator: Kishwer Nehal, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Investigators
Principal Investigator: Kishwer Nehal, MD Memorial Sloan Kettering Cancer Center
More Information

Additional Information:
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
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell