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In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

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ClinicalTrials.gov Identifier: NCT00588315
Recruitment Status : Recruiting
First Posted : January 8, 2008
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):

December 24, 2007
January 8, 2008
October 2, 2017
November 1999
December 2018   (Final data collection date for primary outcome measure)
The study is a descriptive one. No formal statistical testing of correlations will be performed. [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00588315 on ClinicalTrials.gov Archive Site
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In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

This study investigates new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.

The integrated handheld CSLM-OCT device will provide the first truly co-registered images of en face "optical section" planes (confocal) with orthogonal "optical section" planes (OCT).

The imaging with a polarization-sensitive hyper-spectral dermoscope (SkinSpect) will add to the interpretation of CLSM images. SkinSpect will produce tissue-level functional data (i. e., skin chromophore maps of melanin and hemoglobin) in larger fields of view, which will be combined with the cellular-level detail from CLSM imaging. The combined approach will be tested for more accurate detection of skin morphologic characteristics.

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Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Non-Probability Sample
Patients of the Dermatology, Clinical Immunology Services, Pediatrics and Radiology Oncology departments that are determined to have a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy will be offered the opportunity to participate in the study.
Skin Cancer
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  • 1
    skin lesions
  • 2
    normal skin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than or equal to 10 years of age.
  • Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
  • Healthy volunteer subjects older than or equal to 10 years old.
  • Ability to give informed consent.

Exclusion Criteria:

  • Patients who are allergic to fluorescein sodium.
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
Yes
Contact: Allan Halpern, MD 646-888-6013
Contact: Ashfaq Marghoob, MD 646-888-6017
United States
 
 
NCT00588315
99-099
No
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Allan Halpern, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
September 2017