Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis

OHSU Knight Cancer Institute24 enrolled

Overview

The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

VivaScope SystemDEVICE

VivaScope System, Model#s 1500 and 2500

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 12 or older * Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study * Signed informed consent Exclusion Criteria: * Age \< 12 years

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Outcomes

Primary Outcomes

Sensitivity of confocal microscope to improve melanoma detection

Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.

Time frame: Up to 1 year

Specificity of the confocal microscope to improve melanoma detection

Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis

Time frame: Up to 1 year

Secondary Outcomes

Patterns seen on the confocal image

Evaluate and confirm patterns seen on the confocal image, which are characteristic of melanoma and atypical nevi: A) Pagetoid melanoma cells: melanocytes in suprabasal areas of the epidermis B) Irregular dermal-epidermal junction

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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