View Clinical Trial (Medical Research Study)
Evaluation of Optical Imaging for Margin Delineation of Non-melanoma Skin Cancers
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Skin Cancer |
| Purpose: |
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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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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
1. Patients who will be undergoing surgery to remove a region of skin suspected of
containing non-melanoma skin cancer will be eligible to participate in this study.
The proposed resection should be equal or greater than 1 cm in diameter.
2. In addition, patients undergoing induction chemotherapy or biologic therapy prior to
surgical resection are also eligible.
3. Patients must sign an informed consent indicating awareness of the investigational
nature of this study.
Exclusion Criteria:
1. Patients with non-melanoma skin cancer lesion at eyelid, or in case that the lesion
extends to superior or inferior eyelid, this area will not be imaged.
2. Persons who are medically unfit to undergo resection of skin lesions.
3. Persons under the age of 18.
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| NCT ID: |
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NCT00432471 |
| Primary Contact: |
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Principal Investigator
Ann M. Gillenwater, MD
M.D. Anderson Cancer Center
Ann M. Gillenwater, MD
Phone: 713-792-6520
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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