Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432471
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2007-02-05
Brief Title:
Optical Imaging of Skin Cancers for Margin Delineation of Non-Melanoma Skin Cancers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of Optical Imaging for Margin Delineation of Non-Melanoma Skin Cancers
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 55 patients will take part in this study All will be enrolled at MD Anderson
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 55 patients will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21DE016485-01 | NIH | None | None |
| NCI-2015-01901 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearch1R21DE016485-01 |