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Multi-Wavelength and Coherence Confocal Reflectance Microscopy of Pigmented and Non-Pigmented Lesions on the Skin In-Vivo

18 Years
Open (Enrolling)
Basal Cell Carcinoma, Melanoma, Non-Malignant Skin Disorders, Squamous Cell Carcinoma

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Trial Information

Multi-Wavelength and Coherence Confocal Reflectance Microscopy of Pigmented and Non-Pigmented Lesions on the Skin In-Vivo

Patients will be imaged with the Vivascope 1500m multiwavelength coherence microscope during
a single patient visit. The lesion will be photographed with high resolution photography and
surface epiluminescence microscopy. The clinically uninvolved site will be imaged in the
same manner.

The lesion will then be prepped for RCM imaging. A skin contact device consisting of a metal
ring and template will be applied to the skin surrounding the lesion of interest with a
disposable medicalgrade adhesive plastic disc. A wetting solution will be placed into the
metal ring. The wetting solutions include water, mineral oil and other over the counter
products (e.g. hairstyling gel and moisturizing agents). Application of these agents
diminishes artifacts caused by light scattering at the skin surface. RCM images of the
lesion will be captured through the contact device using the Vivascope 1500m surface
confocal microscope provided by Lucid Technologies, Inc. Two types of images will be
collected, VivaBlocks and VivaStacks. VivaBlocks are a 4x4 mosaic of confocal images that
measure 2mm x 2mm in total area. These VivaBlock images are optically combined or "stitched"
together by the VivaScope 1500m to create a seamless representation of 4 mm 2 area at a
specific depth within the skin. VivaStacks are eight 0.5mm x 0.5mm confocal images taken at
3 micron intervals from the keratin layer to the superficial dermis. VivaStacks and
VivaBlocks will be acquired for both the skin lesion and for the clinically uninvolved area
of the skin. The total estimated imaging time for a patient in this study is about 30
minutes for the lesion and the clinically uninvolved site.

The confocal imaging session and the dermatologic visit for the punch biopsy do not have to
occur during the same patient visit. All lesion images will be saved on a network server for
later review and analysis. All imaging will be completed by trained research staff familiar
with confocal imaging.

Inclusion Criteria:

- Patients with a pigmented or nonpigmented skin lesion undergoing biopsy.

- Lesion located on an anatomical site that is readily accessible to the VivaScope
1500m (for example, chest, back, legs, arms, cheek, forehead).

- Ability to sign informed consent, which indicates the investigational nature of this

- Age ≥ 18.

Exclusion Criteria:

- Biopsy located on an anatomic site that is not amenable to confocal imaging (for
example, adjacent to the nose, ears or eyes, fingers, toes).

- Inability to give informed consent.

- Known hypersensitivity to adhesive rings.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

To evaluate and quantify image information and image quality provided by multiwavelength and coherence RCM.

Outcome Time Frame:

once while on study

Safety Issue:


Principal Investigator

Allan Halpern, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

November 2013

Related Keywords:

  • Basal Cell Carcinoma
  • Melanoma
  • Non-Malignant Skin Disorders
  • Squamous Cell Carcinoma
  • skin disorders
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell
  • Melanoma
  • Skin Diseases



Memorial Sloan Kettering Cancer Center New York, New York  10021