This trial is active, not recruiting.

Condition melanoma
Sponsor University of Virginia
Start date March 2008
Trial size 200 participants
Trial identifier NCT00937690, 13564


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.).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
patients and volunteers with cutaneous lesions, with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions

Primary Outcomes

preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter
time frame: one day - 24 hours

Secondary Outcomes

to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis
time frame: one day-24 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Pilot Study of Infrared Imaging of Cutaneous Melanoma
Principal investigator Craig L Slingluff, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University of Virginia.