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OpenTrials
Completed

NCT Number: NCT00937690

Pilot Study of Infrared Imaging of Cutaneous Melanoma

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.).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter

    Time frame: one day - 24 hours

Secondary outcomes

  1. to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis

    Time frame: one day-24 hours

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Acronym: MEL49

Important dates

Study start
2008
Primary completion
2009
First posted
Jul 13, 2009
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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