In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588315
First received: December 24, 2007
Last updated: June 20, 2016
Last verified: June 2016

December 24, 2007
June 20, 2016
November 1999
December 2017   (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 ] [ Designated as safety issue: No ]
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 2017
December 2017   (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.
Both
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
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP