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Pilot Study of Infrared Imaging of Cutaneous Melanoma

Pilot Study of Infrared Imaging of Cutaneous Melanoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00937690
Acronym
MEL49
Enrollment
74
Registered
2009-07-13
Start date
2008-03-31
Completion date
Unknown
Last updated
2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

melanoma, cutaneous, imaging

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.).

Interventions

None listed

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameterone day - 24 hours

Secondary

MeasureTime frame
to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasisone day-24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026