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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01556503
• Other study ID #: IRB00006939
• Secondary ID: CPC-11033-L
• Status: Active, not recruiting
• Phase: N/A
• First received: March 12, 2012
• Last updated: November 17, 2014
• Start date: April 2011

Study information

• Verified date: November 2014
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Melanoma

Intervention

Device:
• VivaScope System
VivaScope System, Model#s 1500 and 2500

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year	No
Primary	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	Up to 1 year	No
Secondary	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	Up to 1 year	No