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Trial record 16 of 2149 for:    Oral Cancer | NIH

Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions

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ClinicalTrials.gov Identifier: NCT00502580
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : July 30, 2012
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date July 13, 2007
First Posted Date July 17, 2007
Last Update Posted Date July 30, 2012
Study Start Date July 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2010)
Evaluate new imaging technology, MDM (Multispectral Digital Microscope), as a tool for early diagnosis of oral neoplasia [ Time Frame: 4 Years ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00502580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions
Official Title Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions
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
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 people's 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Pictures of suspicious and normal oral cavity lesions along with small sample of oral lesion (2-4 mm each, the size of a small eraser) will be removed or biopsied from the areas imaged.
Sampling Method Non-Probability Sample
Study Population Patients with lesions of the oral cavity mucosa.
Condition Oral Cancer
Intervention Behavioral: Interview
Interview taking about 10 minutes to complete.
Study Groups/Cohorts 1
Patients with lesions of the oral cavity mucosa.
Intervention: Behavioral: Interview
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 16, 2007)
45
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Subjects with lesions of the oral cavity mucosa or suspicious for malignancy or premalignancy.
  2. Subjects with the ability and willingness to sign an informed consent and authorization.
  3. Subjects who develop new lesions or alterations in long-standing lesions are eligible, but not required, for re-examination with informed consent.

Exclusion Criteria:

  1. Persons who are medically unfit to undergo superficial punch biopsies of oral mucosa.
  2. Persons under the age of 18.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00502580
Other Study ID Numbers 2004-0684
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2012