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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis|
- Sensitivity of confocal microscope to improve melanoma detection [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis
- Patterns seen on the confocal image [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
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
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.
Device: VivaScope System
VivaScope System, Model#s 1500 and 2500
Other Name: Confocal Microscope
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556503
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Eric Simpson firstname.lastname@example.org|
|Principal Investigator: Eric Simpson|
|Principal Investigator:||Eric Simpson||OHSU Knight Cancer Institute|