Pilot Study of Infrared Imaging of Cutaneous Melanoma

Completed

• Conditions: Melanoma

• Registration Number: NCT00937690
• Lead Sponsor: 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.).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2009-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter	one day - 24 hours

Secondary Outcome Measures

Name	Time	Method
to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis	one day-24 hours

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States