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Pilot Study of Infrared Imaging of Cutaneous Melanoma (MEL49)

This study has been completed.
Information provided by (Responsible Party):
University of Virginia Identifier:
First received: June 1, 2009
Last updated: December 19, 2014
Last verified: December 2014
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.).


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study of Infrared Imaging of Cutaneous Melanoma

Resource links provided by NLM:

Further study details as provided by University of Virginia:

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

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

Enrollment: 74
Study Start Date: March 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: University of Virginia Identifier: NCT00937690     History of Changes
Other Study ID Numbers: 13564
Study First Received: June 1, 2009
Last Updated: December 19, 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 processed this record on June 23, 2017