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Pilot Study of Infrared Imaging of Cutaneous Melanoma

NCT ID: NCT00937690

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Brief Summary

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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

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Conditions

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Melanoma

Keywords

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melanoma cutaneous imaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig L Slingluff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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13564

Identifier Type: -

Identifier Source: org_study_id