Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502580
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2007-07-13
Brief Title:
Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions
Status:
COMPLETED
Status Verified Date:
2012-07
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:
To obtain data to evaluate whether multispectral digital imaging can assist clinicians to screen for premalignant lesions in the oral cavity Our system will illuminate tissue with monochromatic light to excite fluorescence and polarized white light to generate reflectance exposing abnormalities for real time clinical diagnosis
Primary Objectives
1 To compare fluorescence images of oral mucosa lesions obtained at 350 nm 380 nm 400 nm and 450 nm excitation to standard white light images and pathologic analysis of biopsied tissue
2 To compare reflectance images of oral mucosa lesion obtained using broadband polarized light to standard white light images and pathologic analysis of biopsied tissue
3 To develop algorithms to discriminate between normal and abnormal tissue
4 To analyze images to determine which type of optical information or combination thereof yields the most diagnostically useful data
Primary Objectives
1 To compare fluorescence images of oral mucosa lesions obtained at 350 nm 380 nm 400 nm and 450 nm excitation to standard white light images and pathologic analysis of biopsied tissue
2 To compare reflectance images of oral mucosa lesion obtained using broadband polarized light to standard white light images and pathologic analysis of biopsied tissue
3 To develop algorithms to discriminate between normal and abnormal tissue
4 To analyze images to determine which type of optical information or combination thereof yields the most diagnostically useful data
Detailed Description:
All tissue and cells are made of tiny particles that give off small amounts of light This light is called fluorescence Scientists have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence Scientists need to better understand whether fluorescence from the oral cavity mouth can be used to tell which cells are abnormal This information can help doctors detect pre-cancers
In order to better understand fluorescence researchers at the Optical Spectroscopy and Imaging Lab Department of Bioengineering Rice University have developed an instrument that can collect and analyze fluorescence without surgically removing any tissue or touching the tissue This instrument takes pictures of oral cavity fluorescence through a microscope The instrument also takes regular live pictures Scientists hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells The instrument is a standard medical microscope similar to ones used by doctors in their offices to examine peoples ears Researchers have attached a special light source to the microscope that provides different colors of light In addition the microscope has a digital camera attached to it so that the researchers can record what they see with the different light colors
In this study a clinician will use the instrument to take pictures of suspicious and normal oral cavity lesions A small sample of the oral lesion 2-4 mm each the size of a small eraser will be removed or biopsied from the areas that are imaged A portion of both the suspicious and normal areas will be taken to pathology for evaluation The biopsy from the normal appearing area is a biopsy that is additional to those you will receive as part of your standard of care Each participant will have 2-4 biopsies performed depending upon how many areas the examiner feels may be suspicious Most people who take part in this study will be having surgery to remove lesions in the oral cavity anyway so the biopsies will be performed at the time of surgery For those participants who are not scheduled to have surgery the biopsies will be performed under local anesthesia in the clinic
All data will be numerically coded to ensure your confidentiality
In addition to the pictures taken and the biopsy a brief interview will be performed by the clinical research staff to discuss possible past local therapies and your personal history of tobacco and alcohol use The interview should take about 10 minutes to complete
You will not be told of any of the experimental findings Information confirming the diagnosis will be made available to your treating physician After this visit and tissue collection your participation in this study will be complete
This is an investigational study A total of 45 patients will take part in this study All will be enrolled at M D Anderson
In order to better understand fluorescence researchers at the Optical Spectroscopy and Imaging Lab Department of Bioengineering Rice University have developed an instrument that can collect and analyze fluorescence without surgically removing any tissue or touching the tissue This instrument takes pictures of oral cavity fluorescence through a microscope The instrument also takes regular live pictures Scientists hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells The instrument is a standard medical microscope similar to ones used by doctors in their offices to examine peoples ears Researchers have attached a special light source to the microscope that provides different colors of light In addition the microscope has a digital camera attached to it so that the researchers can record what they see with the different light colors
In this study a clinician will use the instrument to take pictures of suspicious and normal oral cavity lesions A small sample of the oral lesion 2-4 mm each the size of a small eraser will be removed or biopsied from the areas that are imaged A portion of both the suspicious and normal areas will be taken to pathology for evaluation The biopsy from the normal appearing area is a biopsy that is additional to those you will receive as part of your standard of care Each participant will have 2-4 biopsies performed depending upon how many areas the examiner feels may be suspicious Most people who take part in this study will be having surgery to remove lesions in the oral cavity anyway so the biopsies will be performed at the time of surgery For those participants who are not scheduled to have surgery the biopsies will be performed under local anesthesia in the clinic
All data will be numerically coded to ensure your confidentiality
In addition to the pictures taken and the biopsy a brief interview will be performed by the clinical research staff to discuss possible past local therapies and your personal history of tobacco and alcohol use The interview should take about 10 minutes to complete
You will not be told of any of the experimental findings Information confirming the diagnosis will be made available to your treating physician After this visit and tissue collection your participation in this study will be complete
This is an investigational study A total of 45 patients will take part in this study All will be enrolled at M D 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