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| Descriptive Information Fields | |||||
| Brief Title † | A Pilot Study to Evaluate Optical Spectroscopy and SIAscopy of Pigmented Skin Lesions | ||||
| Official Title † | A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy and SIAscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters | ||||
| Brief Summary | The purpose of this study is to evaluate the physiological correlates of two imaging devices (1)Modified Two Layer Diffuse Optical Spectroscopy (MTL DOS ) and (2)SIAscopy in the evaluation of atypical moles and melanoma. A typical moles and melanoma will have a different optical profile based on physiological parameters compared to benign nevus. The first measured is to determine the hardware variability. From this optical data, a "correction" curve will be developed and this will be applied to all subsequent optical measurements. |
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| Detailed Description | The researcher using special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. Specifically,to compare malignant vs. benign lesions. The skin lesion will be exam and diagnose by the physician. The picture will be obtain by the technician use these two devices before and after the treatment of the lesion. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case Control, Prospective | ||||
| Primary Outcome Measure † | establish the variance of optical measurements in human pigmented lesions (benign and malignant). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Skin Cancer | ||||
| Intervention † | |||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 120 | ||||
| Start Date † | February 2008 | ||||
| Completion Date | February 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00633516 | ||||
| Organization ID | P41-RR01192 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 4, 2008 | ||||
| Last Updated Date | March 4, 2008 | ||||
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