Pilot Study of Infrared Imaging of Cutaneous Melanoma

Melanoma Clinical Trial

— MEL49  

Official title:

Pilot Study of Infrared Imaging of Cutaneous Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937690
• Other study ID #: 13564
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: December 19, 2014
• Start date: March 2008

Study information

• Verified date: December 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preliminary estimate sensitivity of infrared imaging in detecting melanoma metastasis as function of lesion diameter		one day - 24 hours	No
Secondary	to obtain preliminary estimate of specificity of infrared imaging for detection of melanoma metastasis		one day-24 hours	No