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Pilot Study of Infrared Imaging of Cutaneous Melanoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

Pilot Study of Infrared Imaging of Cutaneous Melanoma


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

one day - 24 hours

Safety Issue:

No

Principal Investigator

Craig L Slingluff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

13564

NCT ID:

NCT00937690

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Melanoma
  • melanoma
  • cutaneous
  • imaging
  • Melanoma
  • Skin Neoplasms

Name

Location

University of VirginiaCharlottesville, Virginia  22908