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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00937690 |
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Date of registration:
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01/06/2009 |
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Primary sponsor: |
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Public title:
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Pilot Study of Infrared Imaging of Cutaneous Melanoma
MEL49 |
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Scientific title:
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Pilot Study of Infrared Imaging of Cutaneous Melanoma |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00937690 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig L Slingluff, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma
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Primary Outcome(s)
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preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter
[Time Frame: one day - 24 hours]
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Secondary Outcome(s)
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to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis
[Time Frame: one day-24 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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