Pilot Study of Infrared Imaging of Cutaneous Melanoma (MEL49)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00937690
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):
University of Virginia

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.).

Condition or disease

Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study of Infrared Imaging of Cutaneous Melanoma
Study Start Date : March 2008
Actual Primary Completion Date : September 2009

infrared imaging of cutaneous lesions
patients and volunteers with cutaneous lesions, with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions

Primary Outcome Measures :
  1. preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter [ Time Frame: one day - 24 hours ]

Secondary Outcome Measures :
  1. to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis [ Time Frame: one day-24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and volunteers over the age of 18 with palpable cutaneous skin lesions. Patients of all races and ethnic backgrounds are eligible. Efforts will be made to include pigmented and non-pigmented lesions in participants with a range of skin colors, including skin-colored papules in African-American and Hispanic patients when available.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00937690

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Principal Investigator: Craig L Slingluff, MD University of Virginia

Responsible Party: University of Virginia Identifier: NCT00937690     History of Changes
Other Study ID Numbers: 13564
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by University of Virginia:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas