Pilot Study of Infrared Imaging of Cutaneous Melanoma

NCT00937690 | Completed DMC

• 1 other identifier: 13564
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.).

Conditions

Melanoma

Keywords

melanoma; cutaneous; imaging

Outcome Measures

Primary Outcomes (1)

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

  one day - 24 hours

Secondary Outcomes (1)

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

  one day-24 hours

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Craig L Slingluff, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: July 13, 2009
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)