Pilot Study of Infrared Imaging of Cutaneous Melanoma (MEL49)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00937690
First received: June 1, 2009
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.).


Condition
Melanoma

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis [ Time Frame: one day-24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2008
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT00937690

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Craig L Slingluff, MD University of Virginia
  More Information

No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00937690     History of Changes
Other Study ID Numbers: 13564
Study First Received: June 1, 2009
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
melanoma
cutaneous
imaging

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 30, 2014