Status:
COMPLETED
In Vivo Confocal Microscopy for Pigmented Lesion Diagnosis
Lead Sponsor:
Lucid, Inc.
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Loma Linda University
Conditions:
Skin Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to image pigmented skin lesions suspicious for melanoma with an imaging technology called in vivo reflectance confocal microscopy. This technology uses low intensity laser...
Detailed Description
Patients will be imaged with the VivaScope 1500 reflectance confocal microscope during a single patient visit. The lesion will be photographed with high resolution photography and a high resolution de...
Eligibility Criteria
Inclusion
- Patients undergoing biopsy for a pigmented lesion suspicious for malignancy.
- Patients undergoing biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
- Ability to give informed consent.
Exclusion
- Lesion suspicious for melanoma located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
- The lesion (suspicious for melanoma) is located on soles of the feet or palms of the hands.
- Inability to give informed consent.
- Known hypersensitivity to adhesive rings.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT00785369
Start Date
August 1 2008
End Date
December 1 2009
Last Update
October 3 2012
Active Locations (6)
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1
Loma Linda University
Loma Linda, California, United States, 92354
2
VA Loma Linda Health Care System
Loma Linda, California, United States, 92357
3
Skin and Cancer Assoicates
Plantation, Florida, United States, 33324
4
Memorial Sloan-Kettering Cancer Center
Hauppauge, New York, United States, 11788