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

OHSU Knight Cancer Institute

Status: Completed

Conditions: Melanoma

Treatments: Device: VivaScope System

Study type: Observational

Funder types: Other

Identifiers

NCT01556503

CPC-11033-L (Other Identifier)

IRB00006939

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Pigmented Lesion

Description:

Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.

Treatment:

Device: VivaScope System