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In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00588315
Recruitment Status : Active, not recruiting
First Posted : January 8, 2008
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

The purpose of this study is to investigate 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 High-resolution OCT (Apollo Medical Optics) device can provide both cross-sectional and en-face images with cellular information. Real-time color images through the same objective with OCT are also provided to show the OCT imaging location of lesion. The color image can be registered simultaneously on a larger dermoscopic image obtained by an external dermoscope. The imaging mode of cross-sectional, en-face and color image can be switched arbitrarily to align the lesion and obtain high-resolution images efficiently. The total imaging time is around 10 to 15 minutes depending on the number of images to be obtained.

To help identify more diagnostic features of optical imaging and better understand their histology correlation, we have developed a novel technique called "precision biopsy". Precision biopsy is an optical imaging guided, feature-targeted mini-biopsy. Once the feature of interest is identified and isolated by the optical imaging, a 2.0 mm punch biopsy is performed. Besides cosmetic benefit of minimal scarring, this tissue sparing biopsy captures the "feature of interest" for histology revelation.

Additionally, the histologic features of precision biopsy will be compared to images gathered by multi-modal optical imaging. The precision biopsy will also be compared to the traditional shave biopsy or shave excision, to determine whether the diagnostic information is comparable between the two methods.

For live remote control (LRC) imaging consultation, MSK dermatologist will based on his clinical examination. An imaging technician will perform the clinical and dermoscopic imaging, while the expert reader will perform confocal imaging remotely via a HIPPA compliant Webex platform.


Condition or disease
Skin Cancer

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Study Type : Observational
Actual Enrollment : 1889 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
Actual Study Start Date : November 1999
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Group/Cohort
skin lesions
The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology
normal skin
The integrated dermoscopic-and-confocal microscopic video-mosaics will be used to compare morphologic patterns and cellular patterns to each other and to the corresponding pathology



Primary Outcome Measures :
  1. The study is a descriptive one. No formal statistical testing of correlations will be performed. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

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): NCT00588315


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Hauppauge (Consent only)
Hauppauge, New York, United States, 11788
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Allan Halpern, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588315    
Other Study ID Numbers: 99-099
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Neoplasms
Skin Neoplasms
Neoplasms by Site
Skin Diseases