In Vivo Confocal Microscopy of Cutaneous Neoplasms & Normal Skin

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00588315
Study type	Observational
Source	Memorial Sloan Kettering Cancer Center
Contact
Status	Active, not recruiting
Phase
Start date	November 1999
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms