Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
Completed
- Conditions
- Melanoma
- Interventions
- Device: VivaScope System
- Registration Number
- NCT01556503
- Lead Sponsor
- OHSU Knight Cancer Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pigmented Lesion VivaScope System Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.
- Primary Outcome Measures
Name Time Method Sensitivity of confocal microscope to improve melanoma detection 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 Up to 1 year Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis
- Secondary Outcome Measures
Name Time Method Patterns seen on the confocal image 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
Trial Locations
- Locations (1)
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States