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In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study

18 Years
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Skin Cancer, Melanoma, Lentigo Maligna

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Trial Information

In Vivo Reflectance Confocal Microscopy for Pigmented Lesion Diagnosis: A Multi-center Study

Patients will be imaged with the VivaScope 1500 reflectance confocal microscope during a
single patient visit. The lesion will be photographed with high resolution photography and a
high resolution dermoscopic device.

The lesion will then be prepared for RCM imaging. A skin contact device consisting of a
metal ring and window will be applied to the skin surrounding the lesion of interest with a
disposable medical grade adhesive. A wetting solution will be placed onto the skin. The
wetting solutions include a high index oil such as a clear cosmetic oil or mineral oil. A
wetting solution such as ultrasound gel will also be placed on the lens of the microscope.
Application of these agents diminishes artifacts caused by light scattering at the skin
surface. RCM images of the lesion will be captured through the window/contact device using
the Vivascope 1500 reflectance confocal microscope provided by Lucid, Inc. Two types of
images will be collected, mosaics and stacks. Mosaics are 12x12 confocal images that are
optically combined or "stitched" together to create a seamless representation of a 6mm x 6mm
total area at specific depths within the skin. Stacks are 0.5mm x 0.5mm confocal images
taken at 5 micron intervals from the keratin layer to the superficial dermis. Mosaics and
stacks will be acquired for the skin lesion. The total estimated imaging time for a patient
in this study is about 10 minutes for each lesion. More than one lesion may be imaged per

After the imaging is complete, the lesion will be biopsied. 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 undergoing biopsy for a pigmented lesion suspicious for malignancy.

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

- Ability to give informed consent.

Exclusion Criteria:

- Lesion suspicious for melanoma located on a site that is not amenable to confocal
imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).

- The lesion (suspicious for melanoma) is located on soles of the feet or palms of the

- Inability to give informed consent.

- Known hypersensitivity to adhesive rings.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To assess the diagnostic accuracy of reflectance confocal scanning laser microscopy(RCM) for melanoma diagnosis when compared to the "gold standard" histopathologic diagnosis.

Outcome Time Frame:

Once while on study

Safety Issue:


Principal Investigator

Allan C Halpern, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center, Manhattan


United States: Institutional Review Board

Study ID:




Start Date:

August 2008

Completion Date:

December 2009

Related Keywords:

  • Skin Cancer
  • Melanoma
  • Lentigo Maligna
  • skin disorders
  • skin cancer
  • melanoma
  • lentigo maligna
  • Skin Neoplasms
  • Lentigo
  • Melanoma
  • Hutchinson's Melanotic Freckle



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Rochester Medical CenterRochester, New York  14642
Loma Linda UniversityLoma Linda, California  92354
VA Loma Linda Health Care SystemLoma Linda, California  92357
Skin and Cancer AssoicatesPlantation, Florida  33324