Pilot Study of Infrared Imaging of Cutaneous Melanoma

Study Overview
=================
Brief Summary
-----------------
Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. Participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).

Official Title
-----------------
Pilot Study of Infrared Imaging of Cutaneous Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients or volunteers with or without a history of melanoma. One or more palpable skin or subcutaneous lesions for which at least one of the following is true: A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1). A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2). A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B). All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry. Exclusion Criteria: Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions. Very fragile skin that may be susceptible to injury from adhesive markers. Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infrared imaging of cutaneous lesions<br>patients and volunteers with cutaneous lesions, with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter |  | one day - 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis |  | one day-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, cutaneous, imaging