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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VivaScope System

Device

VivaScope System, Model#s 1500 and 2500

Other names: Confocal Microscope

Primary outcomes

Sensitivity of confocal microscope to improve melanoma detection

Time frame: Up to 1 year

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

Time frame: Up to 1 year

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

Secondary outcomes

Patterns seen on the confocal image

Time frame: Up to 1 year

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

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 16, 2012
Registry last updated: Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed