In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

Running, not enrolling

Conditions studied: Skin Cancer

In brief

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.

Key facts

Study ID

NCT00588315

Run by

Memorial Sloan Kettering Cancer Center

People needed

1889

Starts

1999-11-01

Expected to finish

2026-12-01

Last updated by the study team

2026-01-07

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients who are allergic to fluorescein sodium.

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
• Memorial Sloan Kettering Hauppauge (Consent only) — Hauppauge, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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