Optical Imaging of Skin Cancers for Margin Delineation of Non-melanoma Skin Cancers
| Tracking Information | |||||
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| First Received Date ICMJE | February 5, 2007 | ||||
| Last Updated Date | March 25, 2013 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate use of fluorescence and reflectance imaging, and confocal microscopy for non-invasive detection of skin tumor margins in head and neck region [ Time Frame: 4 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00432471 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Optical Imaging of Skin Cancers for Margin Delineation of Non-melanoma Skin Cancers | ||||
| Official Title ICMJE | Evaluation of Optical Imaging for Margin Delineation of Non-melanoma Skin Cancers | ||||
| Brief Summary | The goal of this clinical research study is to evaluate an experimental imaging technology, the multispectral digital microscope (MDM), which may help doctors see how far skin cancer extends (widens out) on an area of skin. Researchers want to learn if this new technology can help doctors identify the exact areas involved in precancerous or cancerous changes in the skin. |
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| Detailed Description | All tissue and cells are made of tiny particles that give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Cancerous cells and normal cells also reflect (bounce back) light differently. Researchers want to better understand if light fluorescence and reflectance (a measure of the ability of a material to reflect sunlight) from the skin can be used to tell which cells may be cancerous. Researchers have developed the MDM system in order to better understand how cancer changes the light fluorescence and reflectance in skin. The MDM system shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area through a microscope. The pictures will then be studied to better understand the differences in fluorescence and reflectance in abnormal and normal cells. If you agree to take part in this study, an area of your skin will first be examined under standard white light. A researcher will then use the MDM imaging instrument to take pictures of abnormal-looking and normal skin areas. The researcher will mark 2-4 areas of your skin with a marker. During your surgery, you will have a small sample from a normal-looking area collected and 1 or 2 samples collected, from abnormal-looking areas of the skin. Each sample from abnormal-looking tissue will be about 3-4 millimeters wide (about the size of a small pencil eraser). After the skin lesion has been removed, but before it is needed for review by the pathologist or surgeon, the removed tissue will be examined using the MDM imaging instrument and standard white light. The edges of the removed lesion will then be examined with another type of microscope, a confocal microscope, which allows researchers to see the very small cells in the tissue. The exact location that was imaged with this microscope will be marked on the tissue, and the findings will be recorded. The tissue will then be checked by the pathologist according to standard procedures. You will not be told of any of the experimental findings. Information about the diagnosis will be available to your treating doctor. Your name and any personal identifying information (such as your name, social security number, or medical record number) will be coded to protect your privacy. This is an investigational study. Up to 25 patients will take part in this study. All will be enrolled at M. D. Anderson. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Skin Cancer | ||||
| Intervention ICMJE | Procedure: Optical Imaging
Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area. |
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| Study Arm (s) | Experimental: Optical Imaging
Imaging using the multispectral digital microscope (MDM), a system that shines different colors of light on the skin and takes pictures of fluorescence and reflectance on the skin area.
Intervention: Procedure: Optical Imaging |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 55 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00432471 | ||||
| Other Study ID Numbers ICMJE | 2006-0493 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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